Clinical Trial Coordinator- Finance- FSP

Parexel; Quebec; Hybrid; CAD 60,000 - 90,000; Full time

Job summary

Parexel FSP is seeking a Clinical Trial Coordinator in Kirkland, Quebec. This hybrid role requires at least one day on-site and supports the CRM through the study lifecycle.

Responsibilities include trial/site administration, document management, CTMS/eTMF activities, regulatory submissions, budgeting, and payments, with adherence to ICH‑GCP and company SOPs. Ideal candidates have 1–2 years in clinical research, strong MS Excel and IT skills, excellent communication, and the ability to work in a

Qualifications

• 1–2 years in Clinical Research or healthcare experience.
• Good understanding of Global, Country/Regional Clinical Research Guidelines.
• Hands-on knowledge of Good Documentation Practices.
• Strong MS Excel skills and IT proficiency.

Responsibilities

• Supports the Clinical Research Manager (CRM) and team through the life cycle of the study from start-up to close.
• Trial and site administration including tracking and reporting (Safety Reports, essential documents).
• Document management: prepare, distribute, ship, and archive clinical documents; reconcile eTMF.
• Regulatory & site start-up: assist with submissions, IRB/ERC packages, and approvals.
• Budgeting, agreement and payments: collaborate with finance for country/site budgets, track negotiations, and manage CTRAs.
• Meeting planning: organize investigator meetings and materials.
• Training and SOP adherence: complete required trainings and follow SOPs.

Skills

Clinical Research

GCP (ICH)

MS Office

MS Excel

Documentation & recordkeeping

Budgeting & payments tracking

Communication skills

Time management

Problem solving

Education

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

Tools

CTMS

eTMF

IRB submission software

Job description

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 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.