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) – Positive 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 solutions.
- Positive mindset, growth mindset, capable of working independently with assigned tasks.
- Contributes to CTC team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.

Language Skills

- Fluent in local languages and business proficient in English (verbal and written) and excellent communication skills.

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📌 Clinical Trial Coordinator- Finance- FSP (Quebec City)
🏢 Parexel
📍 Quebec City