Clinical Trial Coordinator; Regulatory; FSP

When our values align, there's no limit to what we can achieve.

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. We take our work personally, we do it with empathy and we're committed to making a difference.

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:
  • Tracking (e.g., essential documents) and reporting (e.g., Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request
• Document management:
  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents
  • Assist with electronic Trial Master File reconciliation
  • Updating manuals/documents (e.g., patient diaries, instructions
  • Document proper destruction of clinical supplies
  • Prepare Investigator trial file binders
  • Execute electronic Trial Master File Quality Control Plan
  • Obtain translations of documents
• 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
  • Obtain, track and update study insurance certificates
  • 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
• Budgeting, Agreement and Payments:
  • Development of country and site budgets (including Split site budget)
  • Tracking and reporting of negotiations
  • Maintenance of tracking tools
  • 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)
  • Payment calculation and execution (investigators, vendors, grants)
  • Ensuring compliance with financial procedures
  • Monitoring and tracking adherence and disclosures
  • Budget closeout
  • Obtain and process Foreign Corrupt Practices Act documentation in a timely manner
• Meeting Planning:
  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support where applicable)
• Compliance with Parexel Standards:
  • Complies with required training curriculum
  • Completes timesheets accurately and timely as required
  • Submits expense reports as required
  • Updates CV as required
  • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

• 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
• Hands on knowledge of Good Documentation Practices
• Good IT skills (Use of MS office, use of some clinical IT applications on…