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Bilingual Clinical Trial Coordinator
1 week ago
As a Clinical Trial Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Clinical Trial Coordinator (CTC)
Trial and site administration:
- Track (e.g. essential documents) and report (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/sign translation change request
Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, track and update study insurance certificates
- Support preparation of submission package for IRB/ERC and support regulatory
- agencies submissions.
- Publish study results for GCTO and RA where required per local legislation
- Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
- Develop, control, update and close-out country and site budgets (including Split site budget)
- Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
- Track and report contract negotiations
- Update and maintain contract templates (in cooperation with Legal Department)
- Calculate and execute payments (to investigators, vendors, grants)
- Ensure adherence to financial and compliance procedures
- Monitor and track adherence and disclosures
- Maintain tracking tools
Meeting Planning:
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Quality & Oversight: (for Senior CTC level)
- Contribute strongly to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Mentors / buddies junior CTCs (including, but not limited to process requirements)
What you need to have:
Clinical Trial Coordinator (CTC)
- Minimum 1-2 yrs in Clinical Research or relevant healthcare experience
- Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
- 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.
- ICH-GCP Knowledge appropriate to role
- Excellent negotiation skills for CTCs in finance area
- Highly 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, both internally and externally.
- Able to work independently taking full ownership of delegated tasks
- Proactive attitude to solving problems / proposing solutions
- To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status
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