Clinical Trial Coordinator- Finance- FSP

Parexel FSP is looking for a Clinical Trial Coordinator with experience with budget negotiation. This position is a hybrid position with 1-day minimum onsite requirement in Kirkland, Quebec.

Job Title: Clinical Trial Coordinator (CTC)

Position Purpose

• Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure.

Organizational Relationships

• Reports to Parexel assigned Line Management with day‑to‑day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.

Primary Responsibilities

• 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 (CTMS) and trackers.
  • Clinical supply & non‑clinical supply management, in collaboration with other country roles.
  • Manage labeling requirements and coordinate/signed translation change requests.
• Document management:
  • Prepare documents and correspondence.
  • Collate, distribute/ship, and archive clinical documents.
  • Assist with electronic Trial Master File (eTMF) reconciliation – updating manuals/documents (e.g., patient diaries, instructions).
  • Document proper destruction of clinical supplies.
  • Prepare investigator trial file binders.
  • Execute eTMF 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 (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.
  • Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation.
• Budgeting, agreement and payments:
  • Collaborate with finance/budgeting representatives for development of country and site budgets (including split site budget).
  • Track and report negotiations and maintain tracking tools.
  • Maintain contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).
  • Update and maintain contract templates in cooperation with Legal Department.
  • Calculate and execute payments (investigators, vendors, grants).
  • Ensure compliance with financial procedures.
  • Monitor and track adherence and disclosures.
  • Close out budgets.
  • Obtain and process Foreign Corrupt Practices Act (FCPA) documentation in a timely manner.
• Meeting planning:
  • Organize meetings (create & track study memos/letters/protocols).
  • Support local investigator meetings (invitation, prepare materials, select venue, support where applicable).
• Training and SOP adherence:
  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
  • Adhere to EP and Client SOPs and processes.

Education and Certification

• B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience.

Skills and Experience

• Minimum 1‑2 years in Clinical Research or relevant healthcare experience. Note – specific experience requirements may vary depending on the Country.
• 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 computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• International Committee on Harmonization (ICH) – Good Clinical Practice (GCP) knowledge appropriate to role.
• Effective time management, organizational and interpersonal skills, conflict management.
• Effective communication with external customers (e.g., sites and investigators).
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to customer focus.
• Able to work independently.
• Proactive attitude to solving problems / proposing solutio