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.

Job Summary
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.

Key Accountabilities
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

Skills





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 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 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 Clinical Trial Coordinator team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required

Knowledge and Experience

Minimum 1-2 years in Clinical Research or relevant healthcare experience Note - Specific experience requirements may vary depending on the Country.

Education

Bachelor's degree (Life Sciences preferred) or equivalent healthcare experience

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