Clinical Trial Documentation Associate

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**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

**You Will Have The Opportunity To**:

- Prepare an ISF and/or TMF, as applicable, along with clinic staff, the ongoing collection and filing of essential documents in the ISF and/or TMF
- Tracks the approval process and updates study team members on the approval status of all clinical trial
- 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
- Compile study documents.
- Ensure accurate and complete documentation of all clinic study source documents, case report forms (CRF) and/or forms according to the company's SOP, GCP and other guidelines.
- Other administrative tasks such as uploading the electronic consent form.

**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 in preparing the source documents for clinical trials is an asset.
- Excellent interpersonal skills and communication skills.
- Excellent organization, multi-tasking skills
- Attentive to details, good initiative and able to work with changing priorities.
- 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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