Clinical Trial Coordinator

5 days ago

Remote, Canada Parexel Full time

Job Title: Clinical Trial Coordinator (CTC) Position Purpose:
The Clinical Trial Coordinator (CTC) is responsible for the following:
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 ExecuPharm (EP) 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). o Ensure collation and distribution of study tools and documents.
- Update clinical trial databases (CTMS) and trackers. o 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 (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).
- Tracking and reporting of negotiations.
- Maintenance of tracking tools.
- Working knowledge of contract development, negotiation, approval, and maintenance (e.g., Clinical Trial Research Agreements (CTRAs)).
- 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 (FCPA) 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).

Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.

Adheres 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.

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

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