At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient.
Parexel FSP is seeking Clinical Trial Coordinators to join our team in Canada! Candidates should 1-2 years of experience in clinical research, bilingual in english and french and be open to go to sponsor's office in Montreal, Kirkland 2x/week.
The Clinical Trial
Coordinator supports the Clinical Research Manager and other team members through the life cycle of the study from study start up to study closure.
Trial and site administration: Update clinical trial databases and trackers Collate, distribute/ship, and archive clinical documents Assist with electronic Trial Master File reconciliation Execute electronic Trial Master File Quality Control Plan Regulatory & Site Start Up responsibilities: Provide to and collect from investigators forms/lists for site evaluation/validation,
site start-up and submissions in a timely manner Support preparation of submission package for Institutional Review Board / Ethics Review Committee and support regulatory agencies submissions Publish study results for Global Clinical Trial Operations and Regulatory Affairs where required per local legislation Development of country and site budgets (including Split site budget) Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements) Updating and maintenance of contract templates (in cooperation with Legal Department) Support local investigator meetings (invitations, prepare materials, select venue, support where applicable) Complies with required training curriculum Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Solid MS Excel skills required International Council for Harmonization ‐ Good Clinical Practice knowledge appropriate to role Effective communication with external customers (e.g., sites and investigators) Demonstrates commitment to Customer focus Contributes to Clinical Trial Coordinator team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required Minimum 1-2 years in Clinical Research or relevant healthcare experience Note - Specific experience requirements may vary depending on the Country. Bachelor's degree (Life Sciences pr #