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OUR CURRENT CAREER OPPORTUNITIES

Want to be inspired?

As an Essential Service Provider, our positions remain open and available

Seeking highly motivated, innovative thinking, medical and scientific professionals.

With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter.  To provide excellence by inspiring enhanced performance to advance medical research and creating a team to drive results.  We take pride in the work we do and welcome all individuals that want to join our dynamic culture and be a part of our brand.

Review our currently available opportunities and explore the possibility of becoming a part of our community of Clinical Research Professionals.

Toronto, Ontario - Clinical Research Coordinator Associate (CRCA)

Duties and Responsibilities:
  • Coordinating conduct of the assigned clinical trial. This includes but is not limited to:
  • Preparation of study related documentation
  • Review and completion of study documents (Case Report Forms and Source Documents)
  • Perform clinical and study procedures as per study protocol as training and experience allows
  • Detailed review of subject and study documentation, case report form (CRFs) and source documents
  • Ensure the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
  • Work with the QA group during Audits and Audit Follow-up and in the development/revision and implementation of Standard Operating for the Phase I and Bioequivalence trials; ensure that the SOPs are consistent with GCP, and regulatory guidelines; review and update SOPs as required
  • Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
  • Participate in staff training sessions
  • Other duties as may be required & as training and experience allow
Qualifications:
  • Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience
  • Certification in Clinical Research is an asset
  • Flexible hours depending on business requirements
  • Rotating shifts and weekend requirements
  • 1+ years’ work experience as a CRC in a CRO (preferably in conducting Phase I / Bioequivalence clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Supervisor, Clinic Logistics

Position Summary: The Supervisor, Clinic Logistics is responsible for all ongoing physical, technical, and administrative functions which support the successful daily operation of the clinic. The supervisor will be accountable for developing and maintaining the clinic inventory of biomedical equipment inclusive of procurement, qualification, as well as all preventative and demand maintenance. This includes maintaining any and all records related to the devices in order to meet or exceed regulatory, sponsor or SOP requirements. The supervisor will be accountable for ensuring the clinic has all the required consumables (medical or otherwise) on hand for the successful completion of a clinical research study. This will include the review of study protocols to ensure compliance. The supervisor will be accountable for maintaining an inventory of appropriate personal protective equipment, staff uniforms, linen, subject necessities, and any additional items that may be required. The supervisor will be accountable for all meal planning, catering delivery, and meal  distribution as well as leadership of the kitchen staff and support for their equipment and logistical needs. The supervisor will oversee all sample bundling and shipments to ensure compliance with all SOP, study protocols and related requirements to ensure sample integrity. The supervisor will be responsible for vendor selection and vendor management in consultation with the Director, Clinic Operations and Finance in accordance with all BPSI policy. The supervisor will be responsible for the bimonthly submission of payroll and for the processing and management of any invoices within the department. The Supervisor, Clinic Logistics key role is to ensure that all biomedical equipment, services, consumables, and processes are always maintained and provided to ensure the continual uninterrupted operation of the clinic. This role is primarily administrative but will require the incumbent to maintain all clinical designations in order to be able to work within the clinic when required for operational needs. Reports to: Director, Clinical Operations Duties and Responsibilities:
  • Develop, monitor and maintain an inventory of all biomedical equipment inclusive of all records related to purchase, qualification, and any preventative or demand maintenance which meets or exceeds regulatory, sponsor, manufacturer or BPSI requirements.
  • Accountable for maintaining all clinic equipment including but not limited to freezers, refrigerators, centrifuges, clinic furniture, clinic task chairs and carts, computers and other business equipment in consultation with related departments and or vendors as required.
  • Provide departmental leadership during internal or external audits for the provision of any records which are requested or required.
  • Develop, report on, and maintain an inventory of consumables (medical and otherwise) that meet or exceed regulatory, sponsor, BPSI or subject requirements with a focus on efficiency, current industry standards and fiscal responsibility.
  • Develop, report on, and maintain an inventory of staff and subject personal protective equipment that meet or exceed regulatory, sponsor, BPSI or subject requirements with a focus on efficiency, current industry standards and fiscal responsibility.
  • Provision of staff uniforms, linen, subject clothing and accessories as required inclusive of vendor management for these services.
  • Accountability and oversight of meal planning, catering delivery, kitchen staff and their equipment, consumables, training and maintenance of qualifications and certifications.
  • Accountability and oversight of sample bundling and shipment and their related SOP development to ensure compliance with sponsor, regulatory, BPSI and other requirements.
  • Accountability for vendor management and any invoicing, purchase orders or vendor selection as required.
  • Responsible for the submission of bimonthly payroll as per BPSI policy.
  • Develop, review and provide feedback as required for all SOPs and study protocols specific to your duties.
  • Responsible for project planning within the department for equipment and consumable implementation, or as a representative for clinical Operations if projects are led by other departments
  • Participation in interdepartmental meetings to ensure Clinical Operation awareness of upcoming studies and projects as it relates to equipment and consumables required for the successful study completion.
  • Provision of input for training development for any new equipment, consumables or PPE provided.
  • Work collectively with the Manager, Clinical Research, Supervisor, Safety Team, and Supervisor, Clinic Support as required in order to maintain operational effectiveness at all times
  • Follow and provide feedback for action plans that address issues with study monitors, sponsors and regulatory agencies.
  • Ensure clinical trial activities are conducted in accordance with the Protocol, SOP, ICH, GCP and applicable regulatory requirements.
  • Ensures the accuracy of the generated data in accordance with protocols, SOP, ICH, GCP and applicable regulatory agencies.
  • Provide insight for the creation and revision of SOP’s and internal procedures.
  • Participates in protocol review and development.
  • Participates in project scheduling, assessing and establishing project milestones.
  • Assist Director, Clinical Operations with day to day activities
  • Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
  • Actively implement action plans to address issues brought up by QA, QC, Study Monitors, sponsors and regulatory agencies.
Qualifications:
  • Knowledge of Good Clinical Practice
  • Able to work in a research setting and aware of the confidentiality that is required
  • At least 4 years’ experience in clinical research or related field
  • Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills
  • Relevant previous supervisory and logistics experience required
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Pharmacy Assistant

Position Summary: Responsible for the overall operation of the Pharmacy including study drugs receipt, preparation and documentation according to study protocols, company policies and procedures. Ensure timely completion of study drug related tasks. Duties and Responsibilities:
  • Review the study protocol for specific study requirements prior to the preparation of pharmacy document and drug dispensing.
  • Receive, prepare and retain study drugs according to study protocol, sponsor and/or applicable Standard Operating Procedures.
  • Coordinate the acquisition of study drugs for method development studies.
  • Interact with Project Management team in regards to the study drug shipment, discrepancies and drug retentions.
  • Responsible in training staff members in assist of drug dispensing and reconciliation.
  • Establish and maintain policies and procedures regarding drug preparation and distribution according to GCP and company SOPs.
  • Ensure timely, accurate and organized completion of assigned tasks within the Pharmacy.
  • Maintain restriction to Pharmacy area.
  • Write and/or revise SOPs as required in accordance to the GCP/ICH, FDA and TPD regulations.
  • Facilitate pharmacy tour/orientation where required.
  • Maintaining all pharmacy equipment and records.
  • Dispose/destroy expired drugs and retention study drugs.
  • Participate clinical meetings and training sessions as required.
  • Provide reports to upper management as required.
  • Execute other duties as assigned.
Qualifications:
  • Graduate from an accredited Pharmacy Technician program from Ontario.
  • Ontario College of Pharmacist Certificate or equivalent may be an asset.
  • Excellent verbal and written English Communication skills.
  • Excellent interpersonal skills.
  • Ability to work both independently and as a team member.
  • Flexible in changing shifts or hours as required by study schedule.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Medical Writer

Duties and Responsibilities:
  • Write and/or review final Clinical Study Report(s) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
  • Assist in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
  • Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
  • Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
  • Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
  • Negotiate timelines with external departments.
  • Compile study documents, as required.
  • Photocopy and scan study documents.
  • Perform other work as assigned.
Qualifications:
  • Minimum university degree, B.Sc. (i.e. Life Sciences)
  • At least 2 years of Medical Writing experience
  • Experience in an CRO environment, preferably in the conduct of Phase I and Bioequivalence studies
  • Good interpersonal and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Quality Control Data Reviewer

Position Summary: Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements. Other responsibilities as assigned. Duties and Responsibilities:
  • Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations
  • Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations
  • Review all other study related documentation: medical screening files, pharmacy labels and files including review of data entry from source documents.
  • Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
  • Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
  • Provide reports of the reviewed data to relevant personnel/department
  • Performs other tasks and projects as assigned
  • Develop and utilize QC Checklist or other QC tools designed to document the QC review process
  • Assist with training of new QC Data Reviewer Staff
  • Participate in review of SOP’s and Protocols
  • Ensure the conduct of clinical trial according the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and Biopharma Services Inc SOP’s at all times (copied from CRC’s responsibility)
Qualifications:
  • Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • 1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO
  • Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
  • Excellent communication skills
  • Excellent computer skills
  • Certification in Clinical Research is an asset.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Crew Chief, Clinical Operations

Position Summary: The Crew Chief, Clinical Operations is responsible for providing leadership, support, and guidance to all Clinic team members, and to coordinate daily operational activities of a study within the department. The Crew Chief leads a team of Clinical Research Technicians (CRTs) and is responsible for all activities related to direct supervision of those staff. The Crew Chief, Clinical Operations will also, in the absence of, and in consultation with, the Supervisor, Safety Team, provide guidance, support and direction to the Safety Team staff as required. The Crew Chief will serve as the main point of contact for any daily operational issues which arise in the clinic. The Crew Chief, Clinical Operations will work on a rotating 12 hour shift schedule in order to provide 24 hour a day coverage to maintain clinic operations. Shift patterns may fluctuate to meet operational needs. The Crew Chief, Clinical Operations key role is providing leadership and ensuring that the daily operation is functioning efficiently and safely, while in accordance with BPSI SOPs and study protocol at all times.  The Crew Chief is to act as a designate for the Supervisor, Clinical Operations, and BPSI, and will be the main point of contact for all clinic related issues 24 hours a day. The incumbent must maintain any BPSI related and required clinical designation they have achieved, and be available to work in the clinic due to operational need. Reports to: Supervisor, Clinical Operations Duties and Responsibilities:
  • Provide leadership, coaching, mentorship, and oversight to all clinic staff and oversight for all daily operational functions.
  • Accountable for staff health & safety in the provision of their duties.
  • Make every effort to prevent or resolve operational issues as, or before they occur and escalate issues to the appropriate member(s) of the leadership team as required.
  • Ensure any and all documentation is completed with regard to any incidents which occur.
  • Report as required on the activities of the clinic to members of management, sponsors or related agencies.
  • Conduct annual performance reviews with front line staff.
  • Be a main point of contact for all clinic related issues and inquiries and act as the designate for the Supervisor, Clinical Operations and BPSI while on shift at all times.
  • Ensure the general clinical duties are performed to prepare for the clinical study and proper monitoring of clinical activities.
  • Oversees the execution of clinical trials; coordinating all clinic activities on study to ensure all clinic needs are met (tasks, subject safety, work schedules, breaks, clinic set-up, etc.)
  • Provide leadership as required during any emergencies or incidences which occur and ensure that the Emergency Response Plan and related SOPs are adhered to and all internal stakeholders are informed appropriately.
  • Keep the Supervisor, Clinical Operations apprised of all incidents and issues which occur through established reporting processes.
  • Follow and provide feedback for action plans that address issues with study monitors, sponsors and regulatory agencies.
  • Ensure that Clinic staff attend onboarding and training, and ensure performance reviews and coaching with staff occurs.
  • Ensure clinical trial activities are conducted in accordance with the Protocol, SOP, ICH, GCP and applicable regulatory requirements.
  • Ensures the accuracy of the generated data in accordance with protocols, SOP, ICH, GCP and applicable regulatory agencies.
  • Provide insight for the creation and revision of SOP’s and internal procedures.
  • Provide input for the maintenance of the clinic calendar, and address short tern scheduling issues as they arise.
  • Review and implement the clinic staff schedule and task assignments
  • Lead, train and coach the team to ensure proper planning, organization and execution of clinical research studies.
  • Actively implement action plans to address issues brought up by QA, QC, Study Monitors, sponsors and regulatory agencies.
Qualifications:
  • Knowledge of Good Clinical Practice
  • Able to work in a research setting and aware of the confidentiality that is required
  • At least 2 years’ experience in clinical research or related field
  • Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills
  • Relevant previous leadership experience required
  • Readily available to work a 12 hour rotating schedule 24 hours a day is a requirement
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Screening Receptionist, Medical Screening Department

Position Summary: Perform all delegated/assigned medical screening tasks in compliance with study protocol, SOPs, GCP and regulatory requirements Duties and Responsibilities:
  • Enter and/or update potential volunteer information in the Recruitment Database
  • Offer study participation and provide tentative study information to potential study volunteers
  • Administer telephone questionnaires to potential study volunteers
  • Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s).
  • Perform screening reception duties including but not limited to ID verification, recording of Demographic information.
  • Build and maintain solid relationship with study volunteers by providing excellent customer service
  • Resolve any volunteer related issues in a professional and timely manner
  • Provide statistical reports to management e.g. month end report, study recruiting stats
  • Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention
  • Liaise with various departments regarding subject participation
  • Help with main reception or clinic check-in as needed
  • Direct calls, volunteers, couriers and visitors to the right person/department promptly
  • Maintain screening related files
Qualifications:
  • A minimum Grade 12 high school diploma
  • 1-2 years’ experience in a customer service environment
  • Strong organizational, time management and planning skills to work independently with efficiency and accuracy
  • Excellent interpersonal and public relation/customer service skills
  • Strong team player with ability to multi-task in a fast-pace environment
  • Experience in dealing with and handling confidential information
  • Proficiency in English, with excellent oral and written communication skills
  • Proficiency in Microsoft Word and Microsoft Excel
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Supervisor, Clinical Operations

Position Summary: The Supervisor, Clinical Operations is responsible for providing leadership, support, and guidance to all Clinic team members, and to coordinate daily operational activities of a study within the department. The Supervisor leads a team of Clinical Research Technicians (CRTs) and is responsible for all activities related to direct supervision of those staff. The Supervisor, Clinical Operations will also, in the absence of, and in consultation with, the Supervisor, Safety Team, provide guidance, support and direction to the Safety Team staff as required. The Supervisor, or their designate, will serve as the main point of contact for any daily operational issues which arise in the clinic.  The Supervisor will also lead a team of Clinic Crew Chiefs, who will act as the Supervisor’s Designate on a 24 hour basis.   The Supervisor, Clinical Operations key role is providing leadership and ensuring that the daily operation is functioning efficiently and safely, while in accordance with BPSI SOPs and study protocol at all times.  The Supervisor will work with Clinical Operations Supervisor of Support and Logistics, and other department leads to find solutions for operational challenges. Any issues that cannot be resolved will be escalated to the Director, Clinical Operations.   The incumbent must maintain any BPSI related and required clinical designation they have achieved, and be available to work in the clinic due to operational need. Reports to: Director, Clinical Operations Duties and Responsibilities:
  • Provide leadership to all clinic staff and oversight for all daily operational functions
  • Provide leadership and oversight to a team of Clinic Crew Chiefs who will act as the Supervisor designate 24/7.
  • Ensure the general clinical duties are performed to prepare for the clinical study and proper monitoring of clinical activities.
  • Oversees the execution of clinical trials; coordinating all clinic activities on study to ensure all clinic needs are met (tasks, subject safety, work schedules, breaks, clinic set-up, etc.)
  • Provide leadership during any emergencies or incidences which occur and ensure that the Emergency Response Plan and related SOPs are adhered to and all internal stakeholders are informed appropriately.
  • Work collectively with the Manager, Clinical Research, Supervisor, Safety Team, Support and Logistics as required, in order to maintain operational effectiveness at all times
  • Follow and provide feedback for action plans that address issues with study monitors, sponsors and regulatory agencies.
  • Ensure that Clinic staff attend onboarding and training, and ensure performance reviews and coaching by and for Clinic Crew Chiefs is occurring
  • Evaluate HR requirements in consultation with Supervisor, Support and Safety Team within the department.
  • Ensure clinical trial activities are conducted in accordance with the Protocol, SOP, ICH, GCP and applicable regulatory requirements.
  • Ensures the accuracy of the generated data in accordance with protocols, SOP, ICH, GCP and applicable regulatory agencies.
  • Provide insight for the creation and revision of SOP’s and internal procedures.
  • Participates in protocol review and development.
  • Participates in project scheduling, assessing and establishing project milestones.
  • Provide input for the maintenance of the clinic calendar.
  • Review and implement the clinic staff schedule and task assignments
  • Assist Director, Clinical Operations with day to day activities
  • Lead, train and coach the team to ensure proper planning, organization and execution of clinical research studies.
  • Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
  • Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings as required.
  • Actively implement action plans to address issues brought up by QA, QC, Study Monitors, sponsors and regulatory agencies.
Qualifications:
  • Knowledge of Good Clinical Practice
  • Able to work in a research setting and aware of the confidentiality that is required
  • At least 4 years’ experience in clinical research or related field
  • Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills
  • Relevant previous supervisory and leadership experience required
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Scientific Medical Writer

Position Summary: The Medical Writer will operate within the Medical Writing department and will develop the Study Protocol and Informed Consent Forms (ICF) for various types of clinical trials such (e.g. BE, BA, phase I – IV clinical trials). The Scientific Medical Writer confirms compliance of the protocol and ICF with different applicable Regulatory authorities’ requirements and ensures for completion and clarity of the information in the protocol and ICF. The Senior Scientific Medical Writer oversees any required updates of the protocol and ICF templates and SOPs within the department. Duties and Responsibilities:
  • Write Phase 1-IV and Bioequivalence Study Protocols and Informed Consent
  • Perform Literature search, NDA review and scientific discussion relevant for designing a study protocol for BE and Phase 1-2a (Proof of concept)
  • Review non-clinical data in preparation to transition to the First in Human clinical
  • Interact efficiently with PK Scientists and Biostatisticians to make sure that the study design is in line with the most updated regulatory and scientific requirements
  • Interact with Institutional Review Boards with respect to Protocols, Informed Consent Forms and other documents as
  • Assist in the development of Standard Operating Procedures (SOPs) and guidelines linked with the department
  • Assist with the preparation for Regulatory agencies and participate if needed in any discussion with the
  • Work closely with scientific, clinical personnel, and the Principal Investigator to ensure that clinical study protocol and other scientific documents are produced to the standard required by Good Clinical Practice (GCP), SOP and other applicable
  • Establish optimal timelines with external departments in order to meet study projects timelines.
  • Perform other work within the Scientific Affairs department as
Qualifications:
  • Minimum University degree, M.Sc. (i.e. Pharmacy, Pharmacology or other Life Sciences relevant degree).
  • At least 2 years of Scientific Protocol design and Writing experience
  • Experience in an CRO environment is an asset preferably in the conduct of Phase I and Bioequivalence studies
  • Excellent scientific writing
  • Excellent interpersonal and communication
  • Attentive to details, good initiative and able to work with changing priorities under tight timelines.
  • Previous participation in Scientific discussion with Agencies (e.g. Scientific Advice meeting in EU, Pre-IND packaging and meeting with FDA) is an asset.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Pharmacokinetic Scientist

Position Summary: The Pharmacokinetic Scientist is responsible for providing scientific expertise for the design, analysis, reporting, and presentation of pharmacokinetic data for various study designs such as BA/BE and Phase I studies. They also provide scientific support to the other company divisions and acts as a scientific consultant with the clients.   Duties and Responsibilities:
  • Performs literature and data evaluation to provide scientific background for clinical studies design
  • Prepares the PK portion of synopses for clinical studies
  • Answers inquiries in process of preparation and reviews study protocols
  • Performs/reviews pharmacokinetic analysis of concentration-time data with the up-to dated software
  • Prepares/reviews the pharmacokinetic section of study reports
  • Interacts and provides input and feedback to Biostatistics Department for data analysis
  • Reviews statistical output to evaluate study results
  • Reviews study reports
  • Provides scientific support to other departments and teams in the areas of pharmacology, pharmaceutics and pharmacokinetics
  • Takes part in revision of the Biopharmaceutics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates
  • Maintains the Biopharmaceutics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated
Qualifications:
  • At least M.Sc in Pharmacy/Pharmacology or related field plus minimum 2 year experience with clinical trials design/data analysis
  • Expertise in the fields of pharmacology and pharmacokinetics
  • Proficiency in the Pk/Stats softwares
  • Proven abilities in literature evaluation, scientific and medical writing and scientific support
  • Demonstrated analytical thinking with strong attention to detail
  • Good organizational skills and ability for multitasking and prioritization
  • CRO experience is asset
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Clinical Research Recruiter

Position Summary: Perform telephone interview and day-to-day activities of Recruiting department.   Duties and Responsibilities:
  • Conduct telephone eligibility screening of potential English-speaking volunteers for inclusion or exclusion in all phases of clinical trials which includes but is not limited to:
    • Reviewing screening criteria,
    • Providing an overview of the study,
    • Responding to volunteer preliminary questions,
    • Capturing brief medical and medication history of volunteers
    • Completion of required paperwork
  • Book appointments for potential volunteers for onsite screening and assign volunteers to studies based on the results of medical screening visits
  • Daily data entry, maintenance and updating of electronic volunteer files into Bio Pharma Services Inc. subject database for telephone recruitment
  • Track statistics for clinical trials including but not limited to fill ratio, advertisement responses, and volunteer no show rates
  • Create documents as required by recruitment and screening processes including, but not limited to:
    • Create Recruitment packages
    • Prepare lists for screening
    • Process referrals and referral payments
    • Master lists for Check-ins
  • Participate in training of new hires if experience allows
  • Involvement in departmental meetings
  • Cooperate with and support the Quality Assurance (QA) group during audit activities
  • Ensure compliance with appropriate BioPharma Services Inc. SOP’s and GCP and ICH guidelines
  • Other duties as may be required & as training and experience allow
Qualifications:
  • Undergraduate degree in sciences or equivalent
  • 1 - 2 years’ experience in a customer service environment and/or call center
  • 1-year work experience in a CRO an asset
  • Previous sales experience preferred
  • Strong organizing and planning skills to work independently with efficiency and accuracy
  • Excellent interpersonal and public relation skills
  • Demonstrated proficiency in English, with excellent oral and written communications skills
  • Decisive, good decision-making skills, able to escalate response to situations when relevant
  • Proficient in Microsoft Word and Microsoft Excel
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Manager, Clinical Data Management

Position Summary: The Manager, Clinical Data Management will manage the activities and employees within the Data Management and data entry groups and work with other groups at BPSI. They will use the necessary expertise to advance the capabilities of the DM team at BPSI in relation to data management, database design and implementation, and to contribute to the effectiveness of DM services including CDISC standards.   Duties and Responsibilities:
  • Manage and mentor the members of the Data Management Group to ensure projects are being successfully executed, per regulations, the contract and industry expectations
  • Manage data management projects to ensure they are on-time and within budget
  • Work collaboratively with the Project Management, Biostatistics, Pharmacokinetic, Scientific and Medical Writing groups, and cross-departmentally within BPSI to meet project deliverables and timelines for clinical data management, statistical programming and reporting
  • Oversee the development of data management systems and processes to meet and exceed regulatory and industry standards of data management for BA/BE and Phase I studies, and as required for Phase II, III and IV
  • Lead and manage the development of Data Management SOPs and training of staff
  • Review SOP from other departments as they relate to DM
  • Manage and document training of employees
  • Oversee performance reviews, goal setting and career development
  • Perform all activities related to data management
  • Develop, test and lock study specific databases and clinical study data for mainly Phase I and BA/BE studies and potentially for Phase II-IV clinical studies
  • Lead the clinical data management process for clinical studies and ensure data coordination are conducted effectively
  • Design and review CRF according to the study protocol
  • Create Data Management Plans (DMP) and other data management documents for projects as required and manage the execution of all plans
  • Develop and review electronic data edit checks for web-based forms
  • Work with data specifications and format, PivotTable tool, data management, functions, and filters
  •  Performs quality control (QC) on study data and programs as needed
  • Create, review, and process data queries and updates the databases
  • Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
  • Manage and assist with data base audits as needed
  • Develop a testing/validation plan for utilizing existing resources and personnel to complete all validation testing within CDM team
  • Research and evaluate software for future data management needs
  • Coordinate with hosting vender
  • Review study specific materials created by other members of the DM group
  • Perform other miscellaneous activities as required
  • Track and report status and progress of data management activities for allocated trials and be proactive to ensure smooth, successful and timely locking of databases
Qualifications:
  • A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company
  • BA or BS, or higher, with a science or related background; equivalent experience in data management and a medical-related field may be substituted
  • In-depth understanding of database structures and database programming
  • In depth knowledge of CDISC SDTM/CDASH standards
  • In-depth knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
  • Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A a plus
  • The proven ability to manage others and think strategically to achieve business goals
  • Strong technical skills in database programming
  • Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
  • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
  • Knowledge of at least one computer programming language is an asset
  • Must have strong communication (both verbal and written), managerial, interpersonal, and client services skills, be highly organized and self-motivated
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Supervisor, Safety Team

Position Summary: The Supervisor, Safety Team is responsible for providing support, guidance and training to the safety team members, and to coordinate operational activities of a study within the department.  The Supervisor leads a team of clinical staff such as RNs Medical Assistants, RPNs, Paramedics and other clinical staff as required, and is responsible for all activities related to direct supervision of those staff. Duties and Responsibilities:
  • Ensure the general clinical duties are performed to prepare for the clinical study and proper monitoring of clinical activities.
  • Oversees the execution of clinical trials; coordinating all clinic activities on study to ensure all clinic needs are met (tasks, subject safety, work schedules, breaks, clinic set-up, etc.)
  • Work collectively with the Supervisor, Clinical Research, and Supervisor, Clinical Operations as required.
  • Analyze and develop action plans to address issues with study monitors, sponsors and regulatory agencies.
  • Organize, oversee and conduct Safety Team staff training, performance reviews and coaching
  • Evaluate HR requirements within the department.
  • Ensure clinical trial activities and conducted in accordance with the Protocol, SOP, ICH, GCP and applicable regulatory requirements.
  • Ensures the accuracy of the generated data in accordance with protocols, SOP, ICH, GCP and applicable regulatory agencies.
  • Write, Revise, and approve SOP’s and internal procedures.
  • Participates in protocol review and development.
  • Participates in project scheduling, assessing and establishing project milestones.
  • Provide input to Clinical Operations, for the maintenance of the clinic calendar.
  • Review and/or approve the Safety Team staff schedule and task assignments
  • Assist Director, Clinical Operations with day to day activities
  • Lead, train and coach the team to ensure proper planning, organization and execution of clinical research studies.
  • Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget.
  • Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings as required.
  • Actively analyze and develop action plans to address issues brought up by QA, QC, Study Monitors, sponsors and regulatory agencies.
Qualifications:
  1. Knowledge of Good Clinical Practice
  2. Updated CPR and ACLS Certification
  3. Able to work in a research setting and aware of the confidentiality that is required in research
  4. At least 4 years’ experience in clinical research or related field
  5. Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills
  6. Relevant previous supervisory and training experience required
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Registered Practical Nurse (Part Time)

Position Summary: To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.   Duties and Responsibilities:
  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Obtain Informed Consent as appropriate
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s)
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • Catheter insertion and removal
  • Perform drug/cotinine screen and alcohol test
  • Proper collecting, handling and processing of PK samples
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (RN & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
  • Write and/or review source documentation forms
  • Serve and/or monitor meals
Qualifications:
  • Education: RPN current registration with regulatory body in Ontario.
  • Current ACLS, BCLS & First Aid certification.
  • Good interpersonal skills, good communication skills.
  • Attentive to details, good initiative and able to work with changing priorities.
  • Computer skills an asset.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Project Coordinator

Position Summary: To assist Project Managers in organizing ongoing projects and potential future opportunities. This task involves, but is not limited to monitoring project plans, schedules, budgets and expenditures, organizing and participating in stakeholder meetings, coordinating study monitor visits and ensuring that project deliverables are met in a timely manner from inception to completion.   Duties and Responsibilities:
  • Maintaining and monitoring project plans, project schedules, budgets and expenditures, and confidentiality agreements.
  • Ensuring projects adhere to frameworks and all documentation is maintained appropriately for each project.
  • Preparing necessary presentation materials for meetings and providing administrative support as needed.
  • Facilitate meetings where appropriate and distribute minutes to all project team members.
  • Documenting and following up on important actions and decisions from meetings.
  • Coordinate and host study monitor visits.
  • Maintain a good understanding of regulatory guidelines (TPD, FDA, EMA, MHRA, ICH, TGA, ANVISA, NMPA) and understanding of basic pharmacokinetics and statistics.
  • Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes proposals and contract templates, weekly tracking reports, financial reports etc.)
  • Assist finance department in developing transfer of pertinent financial information.
  • If required, assist in promotion of BPSI at industry meetings and trade shows.
  • Administrative functions, as required by the position, will include, but will not be limited to data entry, filing, Business Development support, and assisting with Business Development and Marketing related activities as directed by the Vice President of Business Development or Director of Project Management.
Qualifications:
  • Bachelor of Science (B.Sc.) degree or equivalent
  • Relevant background in the healthcare and/or pharmaceutical industry
  • Familiarity with the management of Phase I/BE clinical trials
  • Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
  • Excellent interpersonal, communication and presentation skills
  • Strong organization, prioritization and problem solving skills
  • Ability to manage and handle several projects simultaneously
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Senior Clinical Research Coordinator

Duties and Responsibilities:
  • Coordinates, monitors and supervises all study activities to ensure proper execution of assigned clinical research trials (BE, Phase I, etc.) and to ensure that study protocols, BPSI SOPs, ICH-GCPs and regulatory requirements are met
  • Act as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements
  • Conducts training.
  • Meets with and addresses issue with study monitors, sponsors and regulatory agencies as appropriate
  • Acts as a central communication point for all clinical queries from internal and external customers on the status of their studies
  • Participates in review and development of study protocols, BPSI SOPs, and internal procedures
  • Analyzes and develops action plans to address QA findings, including development of CAPA reports
  • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
  • Maintains adequate, accurate, complete and legible records
  • Detailed review of subject and study documentation, CRFs and source documents
  • Conducts Protocol training for clinical research staff and Investigators.
  • Works with QC and QA during audits and audit follow-ups
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Performs other tasks as assigned and as training and experience allow
Qualifications:
  • Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
  • 3-5 years’ work experience as a Clinical Research Coordinator or similar role in a CRO (preferably in conducting Phase I/IIa clinical trials)
  • Certification in Clinical Research is an asset.
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Ability to work in a fast paced environment with a high degree of organization.
  • Excellent in Microsoft Word and Excel.
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Facility Cleaner

Shift Flexibility:  Mornings 6:00am-2:00pm / Afternoons 14:00-22:00 / Night Shift 22:00-6:00 / Weekends Position Summary: Cleaners are responsible for ensuring that the entire building is kept in a reasonably clean manner, at all times. They must follow their scheduled shifts and prioritize duties accordingly. Most importantly, they are to report all concerns immediately to a supervisor.   Duties and Responsibilities:
  • Washrooms are first priority at the beginning, during and before finishing every shift. If there is a study in progress then this is the starting point of the shift.
  • Ensure all work is done with consideration to health and safety with regards to yourself and all others.
  • Consistently inspect the entire building for cleanliness
  • Dispose garbage from all rooms throughout the building
  • Ensure all the furniture is kept clean
  • Sweep and mop floor surface of the entire building including staircases
  • Ensure all carpets are vacuumed regularly
  • All glass is to be kept clean
  • All doorknobs, walls and countertops are to be wiped
  • Clean lunch room daily as often as necessary
  • Keep outside the building grounds and parking lot clean
  • Seasonal ice/snow remove salt
  • Making of beds throughout Clinic Dormitories
  • Report all problems and concerns to your supervisor, if a concern needs immediate attention and your supervisor is not available please inform an available supervisor.
Qualifications:
  • Minimum High School or equivalent
  • Minimum 1-3 years prior work experience performing related or similar duties
  • Must be able to lift 50 lbs, bend, reach, climb stairs and stand for extended periods of time
  • Scheduling Flexibility:**
  • Must be available to work day, afternoon and weekend shifts (variable shifts) based on business needs. **
  • Hard-working individual
  • Good communication skills
  • Professional mannerism
  • Ability to prioritize assigned tasks
  • Able to multi-task
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Site Compliance/Training Coordinator

Duties and Responsibilities:
  • Ensures that orientation, in-service education, and annual re-orientation is provided to all employees, utilizing lecture, demonstration and audio-visual techniques
  • Assesses departmental and service related training needs. Develops and implements continuous staff training to ensure compliance with all requirements
  • Develops and implements a strategic training plan to ensure staff are trained throughout the company in such a manner as to meet regulatory requirements, improve consumer outcomes, promote cultural sensitivity, and support the overall mission and goals of the company.
  • Develops and implements a plan for periodic reviews of employee training records to ensure employees are receiving necessary training to strengthen existing skills or learn new ones.
  • Support site GCP/GPL/GDP/CGLP training activities – including administration of training plan updates, perform training roster verification and provide applicable training documentation to stakeholders during audit.
  • Ensure compliance with current Standard Operating Procedures, Policies and Work Instructions related to creating training rosters based training assignment email’s, print rosters, follow up, monitor training gaps with assistance from department  managers and create new training plans/rosters for new employees.
  • Prepares, schedules and provides or coordinates in-service training, e-learning and continuing education and notifies all departments of same on a monthly basis
  • Maintains records of and reports employee completion of orientation, annual education, in-service training and continuing education provided by the facility for all staff.
  • Responds to and provides facility-wide training needs as identified by Administration, Program Managers and department heads.
  • Performs other tasks and projects as assigned
Qualifications:
  • Bachelor’s degree in related field or High School diploma or General Education Degree (GED) required.
  • Three (3) or more years of experience developing and deploying Regulatory, Quality and Compliance related training and development programs in a highly regulated environment highly desired
  • Minimum 2-4 years prior work experience performing related or similar duties
  • Good written and verbal communications skills
  • Excellent interpersonal skills with a strong customer service focus
  • Able to organize people and prioritize activities to meet urgent deadlines
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Clinical Research Technician

Duties and Responsibilities:
  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Perform ECG and vitals
  • Compliance check on subjects
  • Collect/process blood and urine samples as well as other specimens as required.
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
  • Catheter insertion and removal
  • Proper collecting, handling and processing of PK samples
  • Process and ship lab samples
  • Assist in drug administration by performing hand and mouth check
  • Serve and/or monitor meals
  • Maintain accurate, complete, legible and timely data entry
  • Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only).
  • Perform data review of the source and/or other related documents as required.
  • Write and/or review source documentation forms
  • Conduct clinical staff training
  • Performs other tasks and projects as assigned
Qualifications:
  • 2 year Medical Technology Diploma, or equivalent
  • 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
  • 1-2 years of recent phlebotomy and ECG experience
  • A minimum of 1 year experience in a basic laboratory setting
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Phase I-Clinical Trial Documentation Specialist

Position Summary: The Phase I-Clinical Trial Documentation Specialist is responsible for overseeing the development and improvement of applicable documentation processes. The Phase I-Clinical Trial Documentation Specialist is also responsible for preparing the clinical trial documentation in the Investigator Site File (ISF) and in the Trial Master File (TMF) for Phase I studies. Furthermore, the Phase I-Clinical Trial Documentation Specialist submits and interacts with the Research Ethics Board (REB) for Phase I studies. Duties and Responsibilities:
  • Leads the development and refinement of applicable documentation systems and processes
  • Prepares an ISF and/or TMF, as applicable, for Phase I studies and collaborate with clinic staff to file the essential documents in the ISF and/or TMF for Phase I studies
  • Coordinates, prepares, and submits appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements) for Phase I studies
  • Serves as the administrative liaison with the Research Ethics Board for Phase I study-related submissions
  • Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required for Phase I studies
  • Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory for Phase I studies
  • Prepares the Regulatory documents (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provides the completed documents to Sponsor/CRO for Phase I studies
  • Compile study documents for Phase I studies
  • Mentor, guide and assist junior member of the clinical documentation team for Phase I study-related documentations, as needed.
  • Establishes an electronic file structure for each clinical trial for use by clinical study team members
  • Assess and implements process and creates Standard Operating Procedures (SOP) for Phase I documentations
  • Perform other duties as required.
Qualifications:
  • BSc, BA, or equivalent experience
  • 5-10 years of administrative experience in clinical trials, with experience in Research Ethics Boards, ISF and TMFs
  • Experience with working, mentoring and managing individuals
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Senior Statistical Programmer

Position Summary: The Senior Statistical SAS Programmer is responsible for the development of SAS codes to create CDISC-compliant data sets (SDTM and ADaM), client-defined analysis datasets, and for the development of SAS code to generate Tables, Listings and Graphs/Figures (TLGs/TLFs) as well as integrated summaries of safety (ISS) and efficacy (ISE), ad hoc analyses and electronic submission deliverables, such as datasets, data documentation, and programs. The Senior Statistical SAS Programmer  provides technical support and planning to develop the SAS macros and oversee the implementation of SAS codes and independently performs the statistical analysis on the clinical study data as outlined in the Clinical Study Protocol and /or Statistical Analysis Plan (SAP), and quality control (QC) checks for TLGs/TLFs. In addition, the qualified individual reviews the clinical study protocol and clinical study report as well as involves in the development of SAP, and works closely with Biostatistician to participate in the validation process of SAS programs on various clinical projects required and works with other teams (PK, Clinical Data Management, Medical Writing) to lead a team of programmers to manage timelines and deliverables.     Duties and Responsibilities:
  • Provide technical support and planning for the development of SAS codes or as per specified in protocol and SAP or the client requires
  • Review data standardization plan, SDTM data specifications, and a study data reviewer’s guide for submitted datasets as per regulatory guidance
  • Prepare ADaM dataset specifications as per required
  • Develop and validate SAS codes for the creation of CDISC datasets (SDTM and ADaM) according to approved datasets specifications for clinical study data
  • Validate SDTM and ADaM datasets and create define.xml file
  • Prepare analysis data reviewer’s guides (ADRG), define.xml and document the CDISC package (programs, validator report, datasets, define.xml, ADRG) for submission purpose
  • Provide training and technical guidance to Statistical Programmers
  • Write and validate SAS codes for the analysis of clinical study data to generate the  complete and accurate statistical tables, listings and graphs/figures (TLGs/TLFs) in according with the study protocol, SAP, and well-defined formats
  • Implement quality control (QC) tasks for the statistical outputs: (TLGs/TLFs) and the QC checks of SAS program as required according to SOPs
  • Review the clinical study protocol and clinical study report as assigned
  • Review SAP and prepare mock shells as required
  • Debug the complex issues of SAS codes in a timely manner to provide ad hoc flexible and rapid SAS programming
  • Work with team to complete the validation of SAS programs on various clinical study data in accordance with validation plan and user requirements specifications as per SOPs
  • Create randomization scheme for clinical studies as needed
  • Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with SOPs and/or clinical trial sponsor’s specific requirements
  • Perform miscellaneous tasks as assigned
  Qualifications:
  • Sc or M.Sc in Computer Sciences, Mathematics, Statistics/Biostatistics, relevant experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
  • Strong SAS hands-on programming skill in the generation of tables, listings, and figures for clinical trials
  • At least 4-year experience with proven SAS skills in clinical trial analysis, CDISC and reporting
  • Excellent organizational skills and ability to delegate and prioritize work to meet tight deadlines while maintaining high standards
  • Proficiency with Microsoft Office
  • Solid knowledge of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines and CDISC requirements
  • Full knowledge and understanding of the processes and procedures used within a statistical programming environment
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients
  • Good interpersonal skills and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Senior Biostatistician

Position Summary: The Senior Biostatistician who will be responsible for application of statistical methods, providing statistical inputs, modifications of SAS codes, validation of SAS codes for clinical study data and generation of Tables, Listings and Graphs as outlined in the Clinical Study Protocol and Data Analysis Plan. The Senior Biostatistician will review clinical study protocol and clinical study report as well as work with PK/PD scientists for the development of the Statistical Analysis Plan and SOPs related to Biostatistics activities. Also, the Senior Biostatistician needs to interact with internal teams and external sponsors, auditors and clients.     Duties and Responsibilities:
  • Provide statistical inputs on study projects, especially in the field of statistical methodologies in study design, sample size estimation, statistical modeling, data handling, analysis and reporting
  • Work with Biostatistics team to develop and validate SAS codes for the analysis of clinical study data, generate output tables, listings and graphs in according with the study protocol and the statistical analysis plan (SAP)
  • Work with PK/PD scientists to prepare SAP
  • Generate randomization scheme for clinical studies
  • Provide technical advice to junior Biostatisticians as well as Statistical Programmers assigned to the program/projects.
  • Work with PK/Biostatistics team to prepare and review SOPs
  • Review statistical outputs and clinical study report
  • Work with Data Management team to provide inputs for the specifications of domains and the creation of CDISC ADaM datasets
  • Provide statistical consultations to the clients
  Qualifications:
  • M.Sc in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
  • Strong experience with statistical methods and modeling
  • At least 3 years of Biostatistician experience in the pharmaceutical industry or in the field of clinical research is required
  • Proficiency with Microsoft Office
  • Good interpersonal skills, good communication skills
  • Attentive to details, good initiative and able to work with changing priorities
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Statistical Programmer

Position Summary: The statistical programmer performs all SAS programming tasks for clinical trial analysis, perform validation for internally developed SAS codes, implements the statistical analysis on the clinical study data, generates the study summary tables, data listings and graphs/figures (TLGs/TLFs) and performs quality control (QC) checks of the statistical outputs (TLGs/TLFs).   This position prepares clinical data from multiple sources, creates derived datasets, executes data specifications to transform clinical study data into Clinical Data Interchange Standards Consortium (CDISC)-compliant data sets (SDTM and ADaM), reviews SDTM specifications, and prepares ADaM specifications, define.xml, and works closely with teams to participate in the validation process of SAS programs on various clinical projects required.       Duties and Responsibilities:
  • Write SAS codes for the creation of SDTM and ADaM datasets as per SDTMIG & ADaMIG for clinical study data
  • Validate SDTM and ADaM datasets and create define.xml file
  • Develop and debug simple to complex SAS programs in a timely manner to provide ad hoc flexible and rapid SAS programming
  • Work with Biostatisticians to complete the validation of SAS programs on various clinical study data in accordance with validation plan and user requirements specifications as per SOPs
  • Execute double programming for newly developed SAS codes and generation of TLFs
  • Maintains documentation for SAS programs and validation results
  • Perform statistical analysis of clinical trial data and generate statistical tables, graphs/figures, and listings for clinical trial data as per study protocol and statistical  analysis plan (SAP)
  • Implement quality control (QC) tasks of the statistical outputs: (TLG/Fs) and the checks of SAS program as required according to SOPs
  • Review study data reviewer’s guide and analysis data reviewer’s guide for submitted datasets as per regulatory guidance
  • Review study protocols, SAP with mock shells, and clinical study report as assigned.
  • Perform miscellaneous tasks as assigned
  Qualifications:
  • Minimum BS (MS preferred) in Computer Science, Statistics, Biostatistics
  • Experience at least 2 years in SAS programming including SAS/BASE, SAS/SQL and SAS/Macros in the pharmaceutical industry.
  • Proficient in the Microsoft Office
  • Knowledge and experience of CDISC
  • Knowledge of FDA, EMA and Health Canada and ICH regulations and guidelines preferred
  • Ability to work effectively as a member of a multidisciplinary research team
  • Ability to work creatively and analytically in a problem-solving environment
  • Ability to prioritize multiple projects and to work with tight deadlines while maintaining high standards
  • Strong attention to detail
  • Effective written and verbal communication skills
  • Self-motivated and detailed-oriented
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Toronto, Ontario - Registered Nurse

POSITION SUMMARY:

To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.

Duties and Responsibilities:

  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Obtain Informed Consent as appropriate
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s)
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • Catheter insertion and removal
  • Perform drug/cotinine screen and alcohol test
  • Proper collecting, handling and processing of PK samples
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (RN & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
  • Write and/or review source documentation forms
  • Serve and/or monitor meals
  • Performs other tasks and projects as assigned
  • Qualifications:

  • Education: RN with current registration with regulatory body in Ontario.
  • Current BCLS/ ACLS & First Aid certification.
  • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
  • Ability to accommodate a flexible work schedule
  • Please send your application to resumes@biopharmaservices.com

    St. Louis, Missouri - Clinical Research Recruiter

    Position Summary: Perform all delegated/assigned recruiting tasks in compliance with study protocol, SOPs, GCP and regulatory requirements. Duties and Responsibilities:
    • Enter and/or update potential volunteer information in the Recruitment Database
    • Offer study participation and provide tentative study information to potential study volunteers
    • Administer telephone questionnaires to potential study volunteers
    • Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s).
    • Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only).
    • Build and maintain solid relationship with study volunteers by providing excellent customer service
    • Resolve any volunteer related issues in a professional and timely manner
    • Provide metrics on advertisement, performance and recruitment activities
    • Provide statistical reports to management e.g. month end report, study recruiting stats
    • Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention
    • Perform any other duties as required permissible by training and experience
    Qualifications:
    • A minimum Grade12 high school diploma, college diploma preferred
    • 1-2 years’ experience in a customer service, call center environment
    • Strong knowledge of medical terminology an asset
    • Strong organizational, time management and planning skills to work independently with efficiency and accuracy
    • Excellent interpersonal and public relation/customer service skills
    • Strong team player with ability to multi-task in a fast-pace environment
    • Experience in dealing with and handling confidential information
    • Proficiency in English, with excellent oral and written communication skills
    • Proficiency in Microsoft Word and Microsoft Excel
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Clinical Research Coordinator

    Duties and Responsibilities:
    • Coordinating conduct of the assigned clinical trial. This includes but is not limited to:
    • Preparation of study related documentation
    • Review and completion of study documents (Case Report Forms and Source Documents)
    • Perform clinical and study procedures as per study protocol as training and experience allows
    • Detailed review of subject and study documentation, case report form (CRFs) and source documents
    • Ensure the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
    • Work with the QA group during Audits and Audit Follow-up and in the development/revision and implementation of Standard Operating for the Phase I and Bioequivalence trials; ensure that the SOPs are consistent with GCP, and regulatory guidelines; review and update SOPs as required
    • Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
    • Participate in staff training sessions
    • Other duties as may be required & as training and experience allow
    Qualifications:
    • Flexible hours depending on business requirements.
    • Rotating shifts and weekend requirements.
    • 1-2 years work experience (preferred) in a CRO with experience in conducting Phase I /Bioequivalence clinical trials.
    • Excellent problem solving, communication, multitasking and interpersonal skills
    • Excellent in Microsoft Word and Excel.
      If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Quality Assurance Auditor

    Position Summary: Responsible for performing the activities of the Quality Assurance Department USA and its team members, to ensure that the Quality Management System is efficiently and effectively implemented, maintained and improved in order to meet or exceed regulatory compliance.  To also provide regulatory guidance to the Management team, staff and Clients, to ensure proper conduct & documentation of clinical studies in accordance with regulatory requirements, in-house standard operating procedures and clinical study protocols.   Duties and Responsibilities:
    • Develops, directs and implements Quality Systems/Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements.
    • Responsible for hosting/coordinating Client Audits and Regulatory Inspections.
    • Coordinate and provide responses to Regulatory queries, deficiency letters, and/or to inspection and Audit observations.
    • Perform audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, TGA, EMA, etc.)
    • Conduct various corporate audits, including audits of equipment maintenance, training records, computer validation and vendor qualification
    • Audit pre-study documentation, in-process activities, end-of-study documentation and clinical study reports
    • Manage the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs.
    • Review Protocols and Informed Consent Forms (ICF)
    • Coordinate GCP training.
    • Provide feedback to the QA Director regarding any Quality issues received internally and from the sponsors, visitors or Regulators.
      Qualifications:
    • University degree in a scientific area, or equivalent.
    • 2-4 years QA experience, preferably including audits of Phase 1 and/or BA/BE studies.
    • Excellent working knowledge of ICH guidelines, GCP, FDA regulations and guidelines
    • Experience writing and reviewing Standard Operating Procedures (SOPs).
    • Excellent hand-eye coordination, organization, multi-tasking, communication and interpersonal skills.
      If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Paramedic (Full Time Night Shift)

    Position Summary: To monitor subject safety during confinement in compliance with the study protocols, SOPs, and regulatory requirements while fulfilling the business needs of the company.   Duties and Responsibilities:
    • Perform ECG, Vital Signs, obtain blood sample and study specific testing
    • Obtain Medical History and Informed Consent from potential trial subjects
    • Explanation of the use of study drug(s)
    • Dispense and Administer study drug(s),
    • Receive physician’s medication order and administer medications from the crash cart
    • Adverse Event Reporting
    • Serve and/or monitor meals
    • Catheter insertion and removal
    • Perform drug/cotinine screen and alcohol test
    • Proper collecting, handling and processing of PK samples
    • Monitor and maintenance of Crash Cart
    • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
    • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
    • Maintain accurate, complete, legible and timely data entry
    Qualifications:
    • Paramedic with current registration with regulatory body in Missouri.
    • Knowledge in Clinical Research and Good Clinical Practice a plus
    • Current BLS and ACLS certifications
    • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Registered Nurse (Full Time Night Shift)

    Position Summary: To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.   Duties and Responsibilities:
    • Perform ECG, Vital Signs, obtain blood sample and study specific testing
    • Obtain Medical History and Informed Consent from potential trial subjects
    • Explanation of the use of study drug(s)
    • Dispense and Administer study drug(s),
    • Receive physician’s medication order and administer medications from the crash cart
    • Adverse Event Reporting
    • Catheter insertion and removal
    • Perform drug/cotinine screen and alcohol test
    • Serve and/or monitor meals
    • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
    • Monitor and maintenance of Crash Cart
    • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
    • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
    • Maintain accurate, complete, legible and timely data entry
    Qualifications:
    • Registered Nurse with current registration with regulatory body in Missouri.
    • Working experience in Clinical Research setting preferred
    • Working knowledge of Good Clinical Practice preferred
    • Current BCLS/ ACLS & First Aid certification.
    • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - PRN Paramedic

    Position Summary:  To monitor subject safety during confinement in compliance with the study protocols, SOPs, and regulatory requirements while fulfilling the business needs of the company.   Duties and Responsibilities:
    • Perform ECG, Vital Signs, obtain blood sample and study specific testing
    • Obtain Medical History and Informed Consent from potential trial subjects
    • Explanation of the use of study drug(s)
    • Dispense and Administer study drug(s),
    • Receive physician’s medication order and administer medications from the crash cart
    • Adverse Event Reporting
    • Serve and/or monitor meals
    • Catheter insertion and removal
    • Perform drug/cotinine screen and alcohol test
    • Proper collecting, handling and processing of PK samples
    • Monitor and maintenance of Crash Cart
    • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
    • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
    • Maintain accurate, complete, legible and timely data entry
    • Perform any other duties as required by Supervisor
      Qualifications:
    • Paramedic with current registration with regulatory body in Missouri.
    • Knowledge in Clinical Research and Good Clinical Practice a plus
    • Current BLS and ACLS certifications
    • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
    • Ability to accommodate a flexible work schedule
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - PRN Registered Nurse

    Position Summary: To monitor subject safety during confinement in compliance with the study protocols, SOPs, and regulatory requirements while fulfilling the business needs of the company. Duties and Responsibilities:
    • Perform ECG, Vital Signs, obtain blood sample and study specific testing
    • Obtain Medical History and Informed Consent from potential trial subjects
    • Explanation of the use of study drug(s)
    • Dispense and Administer study drug(s)
    • Receive physician’s medication order and administer medications from the crash cart
    • Adverse Event Reporting
    • IV Catheter insertion and removal
    • Monitor, assess, and document assessment of peripheral IV insertion and phlebotomy sites
    • Perform drug/cotinine screen and alcohol test
    • Serve and/or monitor meals
    • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI)
    • Monitor and maintenance of Crash Cart
    • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
    • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
    • Maintain accurate, complete, legible and timely data entry
    • Perform any other duties as required by Supervisor
    Qualifications:
    • Registered Nurse with current registration with regulatory body in Missouri or a current NLC/eNLC multistate license
    • Knowledge in Clinical Research and Good Clinical Practice a plus
    • Current BLS and ACLS certifications
    • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset
      Work Hours:
    • Ability to accommodate a flexible work schedule – on an “as-needed basis”
    • No guaranteed minimum hours
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Clinical Research Recruiter

    Position Summary: Perform all delegated/assigned recruiting tasks in compliance with study protocol, SOPs, GCP and regulatory requirements.     Duties and Responsibilities:
    • Enter and/or update potential volunteer information in the Recruitment Database
    • Offer study participation and provide tentative study information to potential study volunteers
    • Administer telephone questionnaires to potential study volunteers
    • Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s).
    • Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only).
    • Build and maintain solid relationship with study volunteers by providing excellent customer service
    • Resolve any volunteer related issues in a professional and timely manner
    • Provide metrics on advertisement, performance and recruitment activities
    • Provide statistical reports to management e.g. month end report, study recruiting stats
    • Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention
    • Perform any other duties as required permissible by training and experience
    Qualifications:
    • A minimum Grade12 high school diploma, college diploma preferred
    • 1-2 years experience in a customer service, call center environment
    • Strong knowledge of medical terminology an asset
    • Strong organizational, time management and planning skills to work independently with efficiency and accuracy
    • Excellent interpersonal and public relation/customer service skills
    • Strong team player with ability to multi-task in a fast-pace environment
    • Experience in dealing with and handling confidential information
    • Proficiency in English, with excellent oral and written communication skills
    • Proficiency in Microsoft Word and Microsoft Excel
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

    St. Louis, Missouri - Phlebotomist/Clinical Research Technician

    Position Summary: Responsible for collecting and processing blood samples from subjects as well as supporting the screening of subjects and ongoing compliance checks, collection of test specimens from subjects, assisting Nursing staff in obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG data, and other activities in support of subject monitoring. Activities will also include processing of blood samples in a laboratory setting and assistance with preparing them for shipment. In addition, will serve meals and assist in keeping the Clinic clean. These activities require that the CRT read, understand, and train to the study protocol provided.   Duties and Responsibilities:
    • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
    • Perform ECG and Vital Signs
    • Collect/process blood and urine samples as well as other specimens as required.
    • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
    • Obtain body measurements, including height and body weight, and calculate Body Mass Index (BMI).
    • Proper collecting, handling, and processing of PK samples
    • Process and ship lab samples
    • Assist in drug administration by performing hand and mouth check
    • Serve and/or monitor meals
    • Maintain accurate, complete, legible and timely data entry
    • Perform screening reception duties as required, including but not limited to ID verification, recording of demographic information
    • Perform data review of the source and/or other related documents as required.
    • Perform any other duties as required by Group Leader, Manager, Designee
      Qualifications:
    • CPR & First Aid certification preferred
    • Phlebotomy certification preferred
    • Flexible hours depending on business requirements.
    • Rotating shifts and weekend requirements
    If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com