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Clinical Research Coordinator

2 weeks ago

Toronto, Canada Think Research Full time

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***ON-SITE ROLE**

**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**

Coordinates, executes and monitors all study activities to ensure conduct of clinical trials in accordance to study protocol, BPSI SOPs and/or Directives, ICH-GCPs and applicable regulatory guidelines.

**You Will Have The Opportunity To**:

- Coordinating conduct of the clinical trials at BPSI. Primarily the type of trials assigned will be standard Bioequivalence studies
- This includes but is not limited to:

- With assistance lead all clinical aspects (excluding recruiting) of assigned Bioequivalence trials
- Act as the point of contact for the clinical group for assigned trials when dealing with internal and external customers
- Preparation of study related documentation
- Review completion of study documents (Case Report Forms and Source Documents)
- Perform clinical and study procedures as per study protocol as training and experience allows
- Ensure the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
- Work with the QA group during Audits and Audit Follow-up and in the development/revision and implementation of Standard Operating for the Bioequivalence trials; ensure that the SOPs are consistent with GCP, and regulatory guidelines; review and update SOPs as required
- Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
- Participate in staff training sessions
- Other duties as may be required & as training and experience allow

**What You Will Bring**:

- Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience
- Certification in Clinical Research is an asset
- Flexible hours depending on business requirements
- Rotating shifts and weekend requirements
- 1+ years’ work experience as a CRC in a CRO (preferably in conducting Bioequivalence clinical trials)
- Excellent problem solving, communication, multitasking and interpersonal skills
- Excellent in Microsoft Word and Excel
- 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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