';
side-area-logo
career

OUR CURRENT CAREER OPPORTUNITIES

Want to be inspired?

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 – Senior 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
  • Preparation of Study Master List, and conducting stand-by lottery at study check-ins
  • Generate recruitment highlights (protocol summary)
  • Informing potential subjects of their medical screening results
  • Assigning tentative subject numbers
  • 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).
  • 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:
  • 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
  • Strong organizational, time management and planning skills to work independently with efficiency and accuracy
  • Strong team player with ability to multi-task in a fast-pace environment
  • Excellent interpersonal and customer service skills
  • Experience in dealing with and handling confidential information
  • Decisive, good problem-solving skills, able to escalate response to situations when relevant
  • Demonstrated proficiency in English, with excellent oral and written communications skills
  • 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

    no later than September 30th, 2019

    Toronto, Ontario - SDTM Programmer II

    Position Summary:
    • SDTM Programmer II will be responsible for all aspects of SAS programming activities within the clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. The SDTM Programmer II will be responsible for communication with project teams, have contact with clients and the responsibility for data management functional oversight of projects assigned.
      Duties and Responsibilities:
    • In synergy with department head (line Manager) create and execute the short & long term vision of the SAS programming activities within Data Management services
    • Annotate case report forms (CRFs) according to the CDISC Implementation Guideline for migration to SDTM.
    • Create SDTM specifications document based on CDISC Implementation Guideline
    • Create CDISC SDTM files, SAS transport files, Define.xml, Define PDFs and Reviewers Guides use for Electronic Submission from the data received in non-standard form from various sources.
    • Prepare documentation on all production programming and validation activities; utilize best industry business practices and data standards for clinical data submissions to the FDA and other global regulatory agencies.
    • Write and maintain documentation of changes to SAS code, programs, and specifications.
    • Independently develop QC programs to validate peer programmers’ SDTM programs and datasets
    • Develop SAS programs to provide complex data listings/reports, data edit checks to support Data Management function to clean data
    • Develop SAS programs to provide patient profiles, missing pages report, coding reports and ad-hoc reports for data review to support the clinical teams
    • Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems
    • Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies
    • Review deliverables before transfer to either internal or external clients
    • Communicate to management on project status and resource issues
    • Write and maintain documentation of changes to SAS code, programs, and specifications.
    • Revise programs for corrections, enhancements, or system environment changes
    • Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines
    • Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
    • Develop SAS programs for SAE/External data ( for example; external lab data) reconciliation and data transfer
    • Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed
    • Other duties & responsibilities as required
      Qualifications:
    • Minimum of 2 to 5 years of SAS programming Experience in CDISC/SDTM (able to develop SDTM datasets)
    • Working knowledge of the relationship and regulatory obligation of the CRO industry with sponsor companies
    • Working knowledge of FDA, GCP, and ICH regulations specific to data management for clinical studies
    • Good working knowledge of CDISC SDTM Implementation Guidelines, regulatory requirements, and the drug development process
    • Demonstrated ability to evaluate research data
    • Quality and Risk Management skills
    • The ability to multi-task and prioritize are essential
    • Strong oral and written communication skills
    • Self-motivated, with the ability to learn quickly and independently
    Please send your application to
    resumes@biopharmaservices.com

    Toronto, Ontario – QC Lab Specialist

    Position Summary:

    Under the direction of the Departmental Manager, reviews documentation and raw data to ensure compliance with the OECD Principles of Good Laboratory Practice, established Standard Operating Procedures (SOPs) and other applicable regulatory requirements.

    Duties and Responsibilities:

  • Review all data generated, ensuring that all documentation is accurate and in accordance with SOPs and regulatory guidance.
  • Co-ordinate various project activities with other departments such as (but not limited to) QA, PK/Stats, Project Management, Business Development and resolve all issues in a very efficient and timely manner.
  • Have flexibility work long hours, to stay late, or come in over weekends to ensure deadlines are met, on an irregular or as-needed basis to ensure project/study deliverables to other stakeholders are met.
  • Provide feedback and findings regarding documentation discrepancies to the Manager, Reporting and QC, and/or Production Supervisor in a timely fashion
  • Prepare bioanalytical tables, reports and plans and respond to any deficiency questions from regulatory agencies.
  • Involve in any audits performed by external auditors, i.e. Canadian HPFBI, US FDA, EU/AU agencies.
  • Must be able to work well and effectively in a team.
  • Exhibits good interpersonal skills, written skills, a professional attitude and motivation to produce consistently high quality work.
  • Any other duties assigned by the Lab Management.
  • In addition to General Responsibilities, the following are additional responsibilities in regards to the conduct of GLP and Non-GLP studies:

  • Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  • Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
  • Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
  • Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.

    • Qualifications:
      • B.Sc. in Analytical chemistry or related subject or College Diploma in chemical engineering or related subject
      • Minimum of 2 years of related experience

        • Required Skills and Experience:
          • Bioanalytical sample analysis and method validation following FDA and EMA guidelines
          • LC-MS/MS Analyst® data and chromatographic interpretation
          • Review (or familiarity) of data generated, ensuring that all documentation is accurate and in accordance with SOPs and regulatory guidances.
          • Review (or familiarity) of bioanalytical study plans, bioanalytical study reports, method validation reports
          • Preparation of data summary tables for sample analysis and method validations
          • Fluent in the use of Microsoft Excel

            • If you have the above Skills and Experience please forward your resume.

            Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Technical Trainer (FT/Contract)


    Duties and Responsibilities:
    • Work in conjunction with QA Department to develop and conduct on-going training program in accordance with ICH GCP, GLP and ISO standards.
    • Conduct staff clinical operations training on clinical study tasks (e.g ECG, Sample collection/processing, AE/SAE, Vital signs, etc).
    • Facilitate the in-house training process for new hires in the clinic.
    • Assess lesson plans, recommend training adjustments and assist with updating training materials, job aids, training videos, testings’ and E-Learning modules, etc.
    • Maintain high visibility to staff within the company during clinical trials and implementation of new trainings.
    • Participate in on-going educational workshops and assist in the establishment of benchmarking best practices to improve professional knowledge and processes.
    • Performs other tasks and projects as assigned.

      • Qualifications:
        • Minimum 2-4 years prior work experience performing related or similar duties is required.
        • Adult Learning and development certificate, Bachelor’s degree in related field, College diploma or General Education Degree (GED) and/or hands-on training experience is an asset.
        • Three (3) or more years of experience developing and deploying Quality and Compliance related training and development programs in a highly regulated environment highly desired.
        • Excellent 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
        • Availability to travel within North America up to 30% of the time is required.
        • Availability to work different shifts and/or weekends.

        Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Marketing Coordinator

    Position Summary:
  • We are looking for a hands on individual with a passion for Marketing that can bring their creativity to the table while gaining valuable experience in the digital marketing world. As a member of the marketing team, you will work closely with sales and operations with the ultimate goal of growing the brand.

  • Duties and Responsibilities:
    • Assist in the development and implementation of B2C and B2B marketing campaigns across relevant channels to ensure effective communications with target audiences.
    • Collaborate with marketing team members to ensure consistent messaging and brand representation on all communications
    • Collaborate with Recruiting department on volunteer recruitment campaigns to grow database and work closely with marketing agency on paid ads
    • Monitor BioPharma’s Facebook and Google My Business accounts to provide timely responses to comments and reviews
    • Identify and share insights from social media monitoring with team members on a regular basis to inform strategies and digital marketing activities
    • Conduct online research and make recommendations to support business goals and enhance social media marketing and engagement activities.
    • Roll out digital marketing campaigns and measure their success using relevant tools

      • Qualifications:
        • Bachelor’s Degree in marketing, digital communications, digital marketing or a related field
        • 2+ years of progressive work experience in digital marketing, analytical research and online advertising
        • Background in clinical research, healthcare or pharmaceutical industry is an asset
        • Strong understanding of current online marketing concepts, strategy and best practice
        • Experience with Google Analytics and Google Ads
        • Understanding of SEO and SEM
        • Design background and experience with Adobe Creative Suite would be an asset
        • Basic understanding of HTML
        • Excellent interpersonal communication skills, both written and verbal with the ability to organize and condense complex information into plain language
        • High energy level with a strong work ethic
        • Ability to work independently and to take direction

        Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Lab Coordinator

    Position Summary:
  • As a Lab Coordinator, you are responsible for supporting the Senior Manager Laboratory Operations with coordinating and continuously improving lab activities, operations, supply chain and performing supportive administrative duties as needed.

  • Duties and Responsibilities:
    • Sample Accession: Receiving, storage and tracking of study samples.
    • Supply Chain: Responsible for ordering, follow-up and maintenance of general lab supply inventories and lab storage room.
    • Database Maintenance: Such as, but not limited to, study samples, reference standards, pipette verification/calibration and staff scheduling.
    • Study Documentation Review: Including verification of good documentation practices and QC review of logbooks and data.
    • Preparation of reagents, stock solutions, mobile phase, reference standard weighing and perform sample extractions.
    • The ability to work towards deadlines due to the time pressured nature of some studies.
    • The ability to utilize word processing, databases, spreadsheets and specialized software on personal computers.
    • Flexibility in working outside of contracted hours and weekends on a rotational basis.
    • Communicate discrepancies to appropriate personnel and assist with problem solving.
    • Coordinate and support lab activities and operations and any other supporting duties as assigned on an as needed basis.
    • In addition to General Responsibilities, the following are additional responsibilities in regards to the conduct of GLP and Non-GLP studies:
    • Work in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
    • Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
    • Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
    • Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study

      • Qualifications:
        • College Diploma in a related science/life science discipline
        • Experience may be substituted with education
        • Working knowledge of computers
        • Customer service skills including attention to detail, accuracy, confidentiality and communication skills
        • Experience working under GxPs
        • Must be able to lift up to 50 lbs, bend, reach, climb stairs and stand for extended periods of time

        Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario – Facility Coordinator Assistant

    Shift Flexibility:
      Shift Flexibility: Mornings 6:00am-2:00pm / Afternoons 14:00-22:00 / Night Shift 22:00-6:00 / Weekends
    Position Summary:
      Facilities are responsible for ensuring that the entire building is at times kept all the clinics are prepared and arranged prior to study entrance. Facilities must follow their scheduled shifts and prioritize duties accordingly. It is very important that any concerns are reported immediately to a supervisor. Facility need to work safely and keep a safe work environment for all others.
    Duties and Responsibilities:
    • Ensure all clinics are prepared and arranged prior to study entrance
    • Arrange clinics according to protocol requirements
    • Perform minor building repairs as needed
    • Ensure clinic bunkrooms are properly prepared before and after each study
    • Assist cleaners to ensure clinics are clean and organized prior to, during and post study
    • Consider the safety of yourself and all others at all times
    • Receive stock
    • Control linen; inventory receive and request pick ups
    • Ensure garbage is controlled and collected efficiently
    • Ensure cardboard is collected and
    • Assist staff as required
    • Prioritize tasks to ensure efficient work environment for all department needs
    • Clean up after meals including removing the garbage
    • Communicate with supervisor or manager that are available in absence of you direct
    • supervisor / manager
    • Other duties as required
    • Must be available to work evenings and weekends
    • Provide 24/7 on-call accessibility to ensure immediate action in case of emergency facility related issues.
    • Other duties including but not limited to (ie. painting, stripping, assembling furniture and waxing of floors) as required
    Qualifications:
    • Minimum High School or equivalent
    • Minimum 1-3 years prior work experience performing related or similar duties
    • Physically fit
    • Able to understand employer’s needs
    • Hard-working individual
    • Good communication skills
    • Professional mannerism
    • Ability to prioritize assigned tasks
    • Able to multi-task
    • 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. **
    Hourly: $18. To $21.
    Group RRSP Program
    Job Type: Part-Time
    Please send your resume to resumes@biopharmaservices.com

    Toronto, Ontario - Clinical Research Study Manager (CRSM-TO)

    Position Summary: Oversee conduct of clinical research studies at BioPharma Services Inc. ensuring compliance with study protocol, SOPs, GCPs and regulatory requirements as well as adherence to the assigned timelines. Lead and coach Clinical Research Coordinators and Clinical Research Assistants to ensure proper planning, organization and execution of clinical research studies. Coordinate and mange Phase I studies in accordance with the protocol, SOPs, GCP guidelines, and applicable regulations, providing guidance and directions to clinic staff.

    Duties and Responsibilities: Responsible for the preparation, co-ordination, monitoring and supervision of all study activities to ensure proper execution of clinical research trials (BE, Phase I, etc.)  This includes study planning, study records preparation, monitoring of subjects and clinical staff activities, and collecting and summarizing study data.  Supports management in overseeing Clinical Trials conducted and through report review.  Participates on cross divisional teams providing clinical expertise and guidance.

    Key Job Responsibilities
    • Reviews protocol pre-study for accuracy, compliance, safety and feasibility of study design
    • Interacts with other clinical staff to plan the logistics of study execution
    • Interacts with SPA/CRC/CRCa/RA/QC to ensure timely completion of pre-study documentation and clinical reports
    • Reviews subject and study documentation, CRFs and source documents
    • Monitors clinical activities during the conduct of the clinical trials
    • Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
    • Participates in the verification and administration of the study drug
    • Oversees the sample transfer/shipment process
    • Reviews, compiles and summarizes clinical data
    • Conducts peer review of clinical study documentation; pre-clinic and post-clinic
    • Ensures projects meet the projected timelines and communicates updates to management and other project team members
    • Evaluates eligibility of volunteers and enrols acceptable volunteers into studies
    • Directly supervises and takes delegated responsibility for the conduct and safety of subjects participating in clinical trials, for adherence to protocols and regulatory requirements
    • Utilizes clinical knowledge to support BPSI in the preparation and execution of more complex clinical trials
    Relationship with Internal/External Customers & Stakeholders 
    • Participates and contributes as a team leader or co-leader of a BPSI Team in planning and executing study projects and provide update study reports.
    • Interacts with personnel from other departments within BPSI to discuss project timelines and problem solve any issues that arise
    • Communicates study requirements and study progress with colleagues and management
    • Develops and maintains a working relationship with members of other departments.
    • Communicates study requirements to subjects
    • Interacts with subjects in a respectful, professional and courteous manner in the performance of day to day activities
    • Co-operates with and supports the activity of Sponsor Monitors/ Auditors/Inspectors
    • Collaborates 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.)
    Problem Solving Analysis
    • Utilises advanced problem-solving techniques to identify root causes of operational problems/issues and determines the best course of action.
    • Investigates and recommends, the usage of new or unconventional problem solving research techniques to the department
    • In consultation with management, develops strategies to address study logistical issues during study preparation.
    • Resolves complex issues with internal/external customers
    • Responds to regulatory agencies to deficiencies in consultation with management
    Decision Making/Autonomy 
    • Demonstrates the ability to make complex interpretation and application decisions within role capacity by utilizing protocol, Standard Operating Procedures and Departmental Practices
    • Reviews issues presented by Sponsor in the conduct of clinical trials and makes recommendations in consultation with management.
    • 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
    Leadership/Professional Development of Self & Others 
    • Monitors and provides feedback to clinic staff regarding their performance on an ongoing basis.
    • Provides management with regular updates concerning staff performance.
    • Provides leadership and guidance to CRC and CRCa
    • Assists in training Clinical Research/Operations staff
    • Completes required training within targeted timelines, initiates professional developmental plan and maintains personal training records.
    • Stay current on changing regulatory and GCP trends, policies and practices as they pertain to the conduct of Clinical studies 
    Compliance & Due Diligence 
    • Conducts duties following established BPSI Standard Operating Procedures and departmental practices and directives in a manner consistent with appropriate regulatory guidelines, GCP requirements and Safe Work Procedures
    • Assists in the creation, development and revision of BPSI Standard Operating Procedures and departmental practices
    • Ensures that clinical staff complete deviation exercises and investigates and implements actions to prevent reoccurrence of deviations by following up with clinical staff
    Other Responsibilities: 
    • Demonstrates corporate values and supports divisional objectives in the performance of work and in interactions with others
    • Executes other duties as may be assigned by management as training and experience allow
    Qualifications:
    • Completed post-secondary 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
    • 3+ years’ work experience in a CRO (preferably in conducting Phase 1/Bioequivalence clinical trials)
    • Excellent problem solving, communication, multitasking and interpersonal skills
    • Excellent in Microsoft Word and Excel
    Salary Range - $50,000 to $100,000.
    Relocation Assistance
    Comprehensive Group Benefits Program
    Group RRSP Program
    Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Senior Leader Phase 1

    Position Summary:
    Responsible for the operational conduct of clinical trials to ensure clinical trial execution is in accordance with study protocols, SOP’s, GCPs and regulatory requirements.
    This role is responsible for the planning, development, implementation, execution, and management of clinical trials which are in alignment with our corporate objectives.

    Qualifications would include:
    Degree in Health Sciences or related discipline (MD or RN preferred)
    Minimum ten years’ experience in clinical research
    Five+ years’ experience in a management role and at least
    Four+ years of relevant experience in a CRO environment managing Phase I-II Bioavailability and Bioequivalence studies

    Relocation Assistance
    Eligible to work in Canada
    Comprehensive Group Benefits Program
    Group RRSP Program
    Job Type: Full-time
    Salary: $100,000.00 to $140,000.00

    Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Bioanalytical Chemist

    Position Summary:
    • Under the direction of the Departmental Manager, performs method validation and biostudy analysis tasks in order to generate analytical test results in compliance with all current applicable Standard Operating Procedures.
    • Duties and Responsibilities:
      • Performs method validation and biostudy analysis tasks in accordance with SOPs.
      • Has a good knowledge of analytical laboratory equipment’s common in the Bioanalytical Laboratory such as sample preparation equipment, general Laboratory equipment and LC-MS/MS.
      • Conduct all work in a good team environment focusing on meeting project timelines.
      • Provides assistance to plan and coordinate projects with responsibility to accommodate frequently changing priorities.
      • Generates analytical test results in compliance with all current applicable Standard Operating Procedures.
      • Generates method procedures, results, validation, re-validation and analytical reports for direct submission to regulatory authorities.
      • Coordinates projects and work activities with Laboratory Management to meet established objectives.
      • Shows innovation on an ongoing basis to assist management in solving problems related to any bioanalytical issues and laboratory processes.
      • Provides assistance in troubleshooting and maintenance of laboratory equipment
      • Assists in reviewing Standard Operating Procedures.
      • Demonstrates excellent written and verbal communication skills.
      • Performs the job in a cost-effective manner.
      • Compiles and archives study/validation data.
      • Performs the job according to an approved Protocols and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
      • Works in a safe manner, complying with all relevant safety procedures and requirements.
      • Exhibits good interpersonal skills, a professional attitude and motivation to produce consistently high quality work.
      • Performs other related duties assigned by the management.
      • In addition to General Responsibilities, the following are additional responsibilities in regards to the conduct of GLP and Non-GLP studies:
        • Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
        • Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
        • Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
        • Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.
        • Qualifications:
          • B.Sc. or College Diploma in Analytical chemistry or related subject
          • Minimum of 1-3 years of related experience
          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
      Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Records Administrator

    Duties and Responsibilities:
    • Perform to company SOP requirements/guidelines and Good Clinical Practices.
    • Compile study documents.
    • Ensure accurate and complete documentation of all clinic study source documents, case report forms (CRF) and/or forms according to company’s SOP, GCP and other guidelines.
    • Photocopy and scan study documents and CRF.
    • Assist with archiving duties.
    • Order Medical Writing supplies when necessary.
    • Perform other duties as required.
      Qualifications:
    • Minimum 1 years of pharmaceutical or clinical experience
    • Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
    • Good interpersonal skills, good communication skills.
    • Attentive to details, good initiative and able to work with changing priorities.
      Please send your application to resumes@biopharmaservices.com

    Toronto, Ontario - Registered Practical 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: RPN current registration with regulatory body in Ontario.
    • Current 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.
    • Ability to accommodate a flexible work schedule
    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
    •   Please send your resume to resumes@biopharmaservices.com

    Columbia, Missouri - Pharmacy Technician

    Reports to:

    Director of Clinical Operations

    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 equipments 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 - Pharmacy Technician Certification Board (PTCB certification)
      • 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 have the above Skills and Experience please forward your resume.

        Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Phlebotomy Lab Coordinator

    Position Summary: The Lab Coordinator is responsible for providing supervision, support, guidance and training to the clinical assistant/clinical research technician’s teams and to coordinate operational activities of a study within the department. The Lab Coordinator leads a team of clinical technical support staff and is responsible for all activities related to direct supervision of staff.

      Duties and Responsibilities:
      • Coordinate phlebotomy lab related study activities to ensure protocol and regulatory requirement(s)are being met. (e.g. sample collection, sample processing, clinic set-up, etc.)
      • Provide input to the clinic calendar
      • Review scheduling of Clinical Research Technicians and Clinic Assistants
      • Responsible for monitoring of study activities
      • Proper collection, handling and processing of Pharmacokinetic (PK) sample(s)
      • Write, review and/or approve source documentation forms
      • Provide input on SOPs, internal procedures related to sample processing, bundling, and shipping, and ensure the accuracy of the generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies
      • Coordinate, Receive, Ship study supplies and/or samples
      • Maintain adequate, accurate, complete and legible records
      • Perform other tasks/duties as assigned by Supervisor

        • Qualifications:
          • Completion of recognized Phlebotomy program or equivalent experience
          • and CPR certification is preferred
          • IATA Shipping Certification preferred
          • Knowledge of good clinical practice
          • At least 2 years’ experience in clinical research or relevant field
          • Computer literacy: Microsoft Office. Good communication skills, problem solving, organizational and leadership skills
          • Relevant previous supervisory and training experience required

          Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri - Phase 1 -Principal Investigator

    Position Summary: Principal Investigator will be responsible for promoting Good Clinical Practice (GCP) in the conduct of Phase 1 clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of the data generated and directing the conduct of the clinical investigation according to government regulations and guidance documents.

    Duties and Responsibilities:
    • Provides Investigator Qualifications and agreements
      • Maintaining a current, up-to-date curriculum vitae
      • Maintaining a current license to practice
      • Demonstrating proper education, training and experience to conduct a clinical investigation
      • Assuming responsibility for the conduct of the clinical investigation
      • Signing all required regulatory documents
      • Disclosing financial disclosure/interest as described by regulations
    • Ensuring Protocol Compliance
      • Possessing a thorough understanding of the requirements of each protocol
      • Determining that the inclusion/exclusion criteria are applicable to the study population
      • Following the trial’s randomization procedures
    • Ensures Initial and Ongoing Review by an IRB
      • Providing the IRB with adequate information to initially review the study
      • Providing the IRB with documents for ongoing review (e.g., protocol amendments, adverse events)
      • Securing written IRB approval prior to initiating a study or instituting any changes to the protocol as approved
    • Determines adequate resources are available to conduct the study
      • Having adequate number of qualified staff to conduct the study
      • Having adequate facilities to conduct the study
      • Ensuring adequate time to conduct and supervise the study
    • Manages the medical care of subjects
      • Responsible for all trial-related medical decisions
      • Assessing subject compliance with the test article and follow-up visits, Evaluating medical history, lab results, vital signs and ECGs
      • Conducting physical examinations
      • Evaluating adverse events
      • Ensuring that medical care is provided to a subject for any adverse event(s)
    • Informing a subject when medical care is needed to treat an intercurrent
    • illness(s)
    • Protects the rights and welfare of subjects
      • Reporting all serious adverse events immediately to the sponsor and IRB
      • Ensuring that the informed consent form contains all the elements required by GCP
      • Obtaining a signed and dated informed consent from each subject prior to initiating any study-related procedures
    • Informing the subject or legal representative about all aspects of the Clinical trial
    • Providing new information about the study
    • Ensures validity of the data reported to the sponsor
      • Ensuring the accuracy, completeness, legibility and timeliness of case report forms
      • Explaining any discrepancies or corrections on case report forms
    • Ensures documentation of study-related procedures, processes and events
      • Documenting deviations from the approved protocol
      • Documenting and explaining premature unblinding of the investigational product
    • Documenting that informed consent has been obtained from the subject
    • Ascertaining the reason for a patient’s premature study withdrawal
    • Documenting adverse events
    • Providing study reports as requested by the sponsor, IRB and regulatory authorities
    • Ensures the proper use and storage of investigational products
      • Being thoroughly familiar with the use of the investigational product(s)
      • Reading the current investigator’s brochure, product insert or other source information
      • Assuming responsibility for the investigational product at the trial site
      • Ensuring the proper use and storage of the investigational product(s) at the trial site
      • Reviewing the proper use of the study articles by the subjects
    • Direct Site Operations
      • Delegating authority and maintaining a delegation of authority list
      • Making available to monitors, auditors, IRB and regulatory authorities all requested trial-related records
      • Ensuring that all staff are informed about their trial related duties and functions
      Qualifications:
    • Current license with no restrictions
    • Current ACLS certification is preferred
    • Current DEA license
    • Able to work in a research setting and aware of the confidentiality that is required in research
    • Experience in Emergency Medicine, Clinical Research or related field an asset
    • Good communication skills, problem solving, organizational and leadership skills
    Please send your application to resumes@biopharmaservices.com

    Columbia, Missouri – 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 (with the exception of blood collection), 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 (if IATA certified)
    • 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 Management

    Qualifications:

    • CRO experience a plus
    • CPR & First Aid certification a plus
    • Phlebotomy certification preferred
    • Flexible hours depending on business requirements.
    • Rotating shifts and weekend requirements

    Please send your resume to resumes@biopharmaservices.com

    Columbia, Missouri – QC Data Reviewer

    Reports To:
      Supervisor, Quality Control  
    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, final report tabulations and PK STAT input and output as assigned
    • 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
    • Perform other duties as assigned by supervisor
      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.
    Please send your resume to resumes@biopharmaservices.com