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OUR CURRENT CAREER OPPORTUNITIES

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With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter. Everything we do – and we do it with passion – is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.

Our BioPharma family is key to our success. We create an environment where the brightest minds have space to innovate. Where there are always new opportunities to learn and grow. Where you can feel at home. Our award-winning dynamic teams, specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials, are at the forefront of medical research advances every day. Could this be the right place for you?

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

Diversity & Inclusion

BioPharma Services is committed to creating an inclusive workforce that encourages, supports and celebrates the diverse voices of our employees from any background. We believe diversity and inclusion drives innovation and makes our company stronger. Our objective is to hire great people and build a culture where difference is valued.

  • IN TORONTO, ONTARIO
  • IN ST. LOUIS, MISSOURI
Toronto, Ontario - Lab Coordinator
Job title
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
Application Process
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
Job title
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
Application Process
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 - Physician Assistant
Job title
Toronto, Ontario – Physician Assistant
Position Summary
The Physician Assistant, under the direction and supervision of a registered Physician, and in accordance with the College of Physicians and Surgeons of Ontario’s policy on delegation, the Physician Assistant (PA) provides medical care to patients based on mutually agreed upon guidelines. 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
  • Dispense and Administer study drug(s)
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event AE monitoring and documentation/ Serious Adverse Event (SAE) Reporting
  • Check-in procedure
  • Assess Lab Results
  • Exercise reasonable care and caution in protecting confidential and sensitive information related to clients
  • Cardiac Monitoring (Telemetry)
  • 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
  • Performs other tasks and projects as assigned
  • Exercise reasonable care and caution in protecting confidential and sensitive information related to clients
  • Conduct screening, physical exams, review blood results, investigation on ECG’s reports,
  • Monitor subjects during and after dosing
Qualifications
  • Certified by the Physician Assistant Certification Council of Canada
  • Eligible to work in Canada/Ontario
  • Effective organizational skills, time management skills, interpersonal skills, problem-solving skills, and communication skills (both written and oral)
  • Experience in a fast-paced primary care clinic environment is an asset
  • Team player willing to roll up their sleeves and become a part of the innovative efforts the clinic is currently undergoing
Application Process
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
Job title
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
Application Process
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, Screening Liaison
Job title
Toronto, Ontario – Clinical Research Recruiter, Screening Liaison
Position Summary
Perform telephone interview and day-to-day activities of Recruitment and screening
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:

o Reviewing screening criteria,
o Providing an overview of the study,
o Responding to volunteer preliminary questions,
o Capturing brief medical and medication history of volunteers
o 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 BioPharma 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:

o Create Recruitment packages
o Prepare lists for screening
o Process referrals and referral payments
o 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
• 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
• 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
• 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

Application Process
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 (Screening)
Job title
Toronto, Ontario – Clinical Research Technician (Screening)
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
  • Perform any other duties as required permissible by training and experience
  • Conduct of procedures according to Protocol and applicable Good Clinical Practice (GCP) guidelines, applicable regulations and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
  • Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other guidelines
  • Obtaining blood/urine samples, obtaining ECG, obtaining vital signs, processing of blood/urine samples for shipment to the appropriate clinical diagnostic laboratory, obtaining subject’s Height, Weight and Frame size
  • Conducting a subject interview
  • Setting up the clinic according to the study requirements (tube labeling, bed set up, photocopying, numbering of files, binding and archival of study files and supporting documents, etc.)
  • Monitor and/or perform clinic activities (meal monitoring, water restriction, subject entrance and subject exit, etc.)
  • Conducting pre-shipment sample inventories and preparing sample shipments
  • Other duties as may be required & as training and experience allow
Qualifications
  • 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-paced 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 2 year Medical Technology Diploma, or equivalent
  • 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 including weekends
Application Process
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 (12 Month Contract)
Job title
Toronto, Ontario – Statistical Programmer (12 Month Contract)
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
Application Process
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 - Advanced Care Paramedic

 

Job title
Toronto, Ontario – Advanced Care Paramedic
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
  • Management and reporting of Adverse Events
  • Catheter insertion and removal
  • Perform drug/cotinine screening, alcohol testing and other procedures as required
  • 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
  • Performs other tasks and projects as assigned
Shift Availability:
  • Available any shifts between 06:00am – next day 06:00am (morning, afternoon or night shift)
Qualifications:
  • MOHLTC Advanced Care Paramedic (ACP) Certificate,
  • Graduate of an Advanced Care Paramedic program through a recognized and accredited Community College or equivalent
  • 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
Application Process
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 Director

 

Job Title:
Toronto, Ontario – Project Director
Position Summary:
Reporting to the Director of Project Management, the Project Director will provide integrated direction, management and leadership in the administrative and project planning, budgeting, and process improvement efforts of Phase I studies and Key Accounts impacting core functions and components across the organization.
Duties and Responsibilities:
  • Directs and integrates the activities of multiple, major project operations; manages a diverse team of professional and support staff, both directly and through managers and/or supervisors.
  • Participates and oversees the development, implementation, and maintenance of individual project objectives.
  • Leads the development of processes and procedures for Phase I projects and its execution as directed by Director of Project Management.
  • Working under the direction of the Director of Project Management champions change and effectively manages the implementation of new strategic ideas and key process improvement initiatives within department or across operational segments of BioPharma Services Inc.; achieves excellence in all areas of business.
  • As needed or assigned, acts as a support/backup to Director of Project Management.
  • Supports and solicits input from team member at all levels within the organization.
  • Continuously defines ways to increase client satisfaction and deepen client relationship; ensures service delivers superior satisfaction to clients and provides senior level resolutions.
  • Lends expertise to internal teams and enforces current policies and procedures.
  • Grows long-term relationship with clients and capitalizes on potential opportunities.
  • Provides leadership and guidance in all aspects of the project life cycle.
  • Maintains a tracking process for the studies managed, including initiation, tracking, timelines reporting, budgeting and report writing.
  • Within scope of position, provides sound scientific advice to clients either directly or via other BPSI staff; co-ordinates teleconferences with appropriate personnel, addresses client questions, concerns and/or comments.
  • Negotiates client’s milestones and assist internal stakeholders as required.
  • Uses appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Director, Project Management and/or Operations Management.
  • Actively participates in the weekly tracking meeting to ensure project timelines are current with the most up-to date information from operations and to update operational team of any new information available from the client.
  • Leads feasibility assessment of complex Phase I projects with key department stakeholders; provides support in the review and development of proposals on as needed basis.
  • Proactively recognizes any change in scope; collaboratively works with Contracts & Proposals team and Business Development to develop and ensure timely completion and issuance of change orders.
  • Follows with existing accounts on new business opportunities and manage activities around outstanding proposals and contracts.
  • Assists 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.
  • Ensures appropriate documents have been reviewed and circulated within BPSI prior to providing to clients.
  • If required, assists in promotion of BPSI at industry meetings and conferences.
  • Maintains a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, NMPA, ANVISA) and understanding of basic pharmacokinetics and statistics.
  • Coordinates client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures.
  • Performs miscellaneous job-related duties and other task as assigned.
Qualifications:
  • Bachelor of Science (B.Sc.) degree or equivalent; at least 5 year of experience directly related to the duties and responsibilities specified.
  • Relevant background in the healthcare and/or pharmaceutical industry.
  • Minimum of 5 years’ experience in a senior project management role in either Phase I/BE or Phase I – IV setting.
  • Excellent understanding of how studies are run and how they are managed.
  • 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 organizational skills with the ability to adapt and adjust to changing priorities, apply and problem-solving skills.
  • Demonstrated ability to independently manage multiple projects simultaneously.
  • Highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint, MS Project).
Application Process
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 (Part Time)

 

Job Title:
Toronto, Ontario – Medical Writer (Part Time)
Position Summary:
The Medical Writer will operate within the Medical Writing team to develop clinical study report for various types of clinical trials such (e.g., BE, BA, phase I – IV clinical trials). The Medical Writer will be required to develop and maintain Quality Control systems and review clinical reports for completion, clarity, and compliance with different Regulatory authorities. The Medical Writer leads the required update of the medical writing templates and the specific department directives.
Duties and Responsibilities:
  • Write and/or review final Clinical Study Report(s) for various types of clinical trials such (e.g., BE, BA, phase I – IV clinical trials) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
  • Ensure the writers’ compliance with different clients’ specifications for all the documents generated by the Medical Writing team.
  • Conduct and maintain the required training for junior Medical Writers.
  • Assist in the development of the 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 experience in CRO clinical study report writing, preferably of Phase I and Bioequivalence studies
  • Good interpersonal and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
Application Process
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 Medical Writer

 

Job Title:
Toronto, Ontario – Senior Medical Writer
Position Summary:
The Senior Medical Writer will operate within the Medical Writing team. Will be required to develop and maintain Quality Control systems and review Clinical Reports for completion, clarity and compliance with different Regulatory authorities. Lead the required update of the medical writing templates. Assist the Junior Medical Writers with the more complex Clinical Reports and conduct training, as appropriate.
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.).
  • Ensure the writers’ compliance with different clients’ specifications for all the documents generated by the Medical Writing team.
  • Conduct and maintain the required training for junior Medical Writers.
  • Assist in the development of the 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 experience in CRO clinical study report writing, preferably of Phase I and Bioequivalence studies
  • Good interpersonal and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
Application Process
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 Data Associate

 

Job Title:
Toronto, Ontario – Clinical Data Associate
Position Summary:
The Clinical Data Associate, working with senior data management members, is responsible for entering clinical study data into an electronic database(s), setup databases, data cleaning/query management and documentation of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards.
Duties and Responsibilities:
  • Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
  • Contributes to the development and testing of study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
  • Editing, processing (data entry) and entry of data into an electronic database from relevant clinical study documentation (e.g., Case Report Forms, Source Documentation)
  • Resolution of database queries, as generated in real-time or following completion of all planned data entry
  • QC review of entered clinical trial data to ensuring accurate and precise entry of all data
  • Identifying issues and queries with study documentation and bringing this to the attention of the direct supervisor (or designate)
  • Adherence to study timelines
  • Performing all work in accordance with BSPI Standard Operating Procedures, relevant regulatory guidelines and study requirements
  • Involved in the management of the process from DMP development to data entry, data cleaning and data transfer
  • Contributes to or writes the Data Management Plan (DMP) and other data management documentation
  • Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
  • Performs quality control (QC) on study data as needed
  • Create, review, and process data queries and updates the database
  • Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
  • Other duties & responsibilities as required
Qualifications:
  • Experience in data entry or Data Management activities, performing activities in relationship to setup, conduct and locking of clinical data
  • BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
  • Understanding of database structures and database programming
  • Knowledge of CDISC standards, especially CDASH and SDTM
  • Knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
  • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
  • Strong analytical and problem solving 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
Application Process
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/Part Time)
Job title
St. Louis, Missouri – Paramedic (Full Time/Part Time)
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.
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumesstl@biopharmaservices.com
St. Louis, Missouri - Director, Clinical Operations
Job title
St. Louis, Missouri – Director, Clinical Operations
Position Summary

Reporting to the VP Global Clinical Operations the Director, Clinical Operations St. Louis Operations is responsible for the execution of the Global aspects of St. Louis trials. General Manager St. Louis Operations will be responsible for the:

  • Manage the operational aspects of clinical studies and operational expenses for the St. Louis Missouri U.S.A. Facility.
  • Meet expectations of corporate goals, timelines, cost and quality performance.
  • The General Manager St. Louis Operations will oversee the planning, development, implementation, execution, and management of assigned clinical trials, as well as participate in other areas requiring scientific/technical expertise.
Duties and Responsibilities
  • Increase management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities
  • Develops strategic plan by studying technological and financial opportunities; presenting assumptions; recommending objectives.
  • Accomplishes subsidiary objectives by establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections.
  • Coordinates efforts by establishing procurement, production, marketing, field, and technical services policies and practices; coordinating actions with corporate staff.
  • Builds company image by collaborating with customers, government, community organizations, and employees; enforcing ethical business practices.
  • Maintains quality service by establishing and enforcing organization standards.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.
  • Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations
  • Directs and supervises all clinical Leads and assigned staff members
  • Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic
  • Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results.  Ensures that high-quality customer service is offered by all clinic employees
  • Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff
  • Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical 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
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements
  • Interacts with Study Monitors, investigators, regulators, vendors, and others external to the Company
  • Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
  • Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings
  • Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies
  • Performs other tasks and projects as assigned
Qualifications
  • Nine or more years’ experience in clinical trials, five years in a management role and at least 4 years of relevant experience in a Clinical Research Organization
  • Significant experience managing Phase I-IIb, Bioavailability and Bioequivalence studies
  • Degree in Health Sciences or related discipline
  • CCRP certification
  • Computer literacy and excellent communication skills
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com

 

St. Louis, Missouri - Registered Nurse (Full Time/Part Time)
Job title
St. Louis, Missouri – Registered Nurse (Full Time/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
  • 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
  • Perform any other duties as required by Supervisor
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.
  • Ability to accommodate a flexible work schedule
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com
St. Louis, Missouri - Phlebotomist
Job title
St. Louis, Missouri – Phlebotomist
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
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com
St. Louis, Missouri - Training Coordinator

 

Job title
St. Louis, Missouri – Training Coordinator
Duties and Responsibilities
  • Act as Departmental Training Coordinator to work with business in meeting training needs through the maintenance of training records and plans, investigation of training plan discrepancies
  • Conduct follow-up function and audit to ensure all documentation training is accurately captured according to agreed upon process timelines
  • Support site GCP 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 and Work Instructions related to creating training rosters based training assignment email’s, print rosters, follow up, monitor training gaps with assistance from Clinical Managers and create new training plans/rosters for new employees.
  • Maintain and update various databases on a daily basis (ie. Reliability, Training Roster Tracking). Follow up and investigate discrepancies as required.
  • Stays up-to-date of documentation, staff qualification, and training requirements outlined in applicable SOP’s, regulations and training matrixes.
  • Develops standardized training curriculums that assure compliance with all regulatory requirements and SOP’s. Monitors training activities, including the maintenance of training records
  • 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 clinic 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.
  • Performs other tasks and projects as assigned
Qualifications
  • 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
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com
What are early phase clinical trials?

Clinical Trials are divided into 4 phases.  Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.

The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects.  Phase 1 trials are conducted in healthy volunteers.

Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.

What is a clinical trial?

A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective.   In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.

What is an investigational drug?

An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:

  • If the drug is safe and effective.
  • How the drug might be used in that disease.
  • How much of the drug is needed.
  • Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?

In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.

Should I expect to experience any side-effects while doing studies?

As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.

Will I be compensated for doing a clinical study?

Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).

Are food and accommodation provided over the course of the trial?

Food – Clinical trials are conducted in a controlled setting which means that all food is provided and  trial volunteers receive standardised meals.  Individual meal plans or meal preferences cannot be provided.  If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial.    Please contact us to discuss any food issues.

Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender.  Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.

What is the length of a study and do I have to complete all the visits?

Details of the duration of a study can be found on the Volunteer Hub.

What is informed consent and how is it carried out?

Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF).  The ICF describes the clinical research study and the nature of the investigational product to be used, including:

  • Your rights and responsibilities as a study participant.
  • What you will be asked to do during study participation.
  • The potential risks that you should be aware of.

During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff.  You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.

Can I bring my own food?

All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video

What do I need to pack?

Wondering what to pack before your site visit? Visit our Packing List page to learn more.

When do I receive compensation for taking part in a study?

You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)

Where will I sleep during the clinical study?

We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video

What COVID-19 precautions are you taking?

The safety of our volunteers is a top priority. Learn more about the measures we are taking to create a safe environment for you.

Can I bring my own device?

Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.

Privacy

We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.