Clinical Trial Documentation Associate - BioPharma Services

The Company

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

Why Us?

• It’s not every day that you have the chance to change the way your friends and family are cared for - Make an impact!
• 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.
• We’re growing, and so will you with leaders who will support your development through mentorship and other opportunities

• Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

The Role

The Associate, Clinical Trial Documentation is responsible for the collection of clinical trial documentation in the Investigator Site File (ISF) and in the Trial Master File (TMF) and the controlled distribution of selected approved documentation. The Clinical Trial Documentation Associate is also responsible in archiving Clinical Study Report (CSR), TMF and ISF. The Associate, Clinical Trial Documentation assist with the submission and interaction with the Research Ethics Board (REB).

You Will Have The Opportunity To:

• Prepare ISF and/or TMF, as applicable, along with clinic staff, the ongoing collection and filing of essential documents in the ISF and/or TMF
• Assist with archiving duties related to clinic documents including but not limited to CSR, TMF and ISF:
• Coordinates, prepares, and submits appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements)
• Tracks the approval process and updates study team members on the approval status of all clinical trials
• Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required
• Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory
• Assist with the compilation, completion, and internal approval process of Regulatory documentation (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provides completed Regulatory documentation to Sponsor/CRO for each study as well as filing in the ISF/TMF.
• Compile study documents according to company’s SOP, GCP and other guidelines.
• Perform other duties as required.

What You Will Bring:

• BSc, BA, or equivalent experience
• Administrative experience in clinical trials
• Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
• Experience in Research Ethics Boards, Investigator Site File (ISF) and Trial Master File (TMF) is an asset
• Experience is preparing the source documents for clinical trials is an asset.
• Excellent interpersonal skills and communication skills.
• Experience in Research Ethics Boards, ISF and TMFs is an asset

Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment.

We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs.

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