Clinical Trial Coordinator - Finance - Montreal
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- Montreal, QC
- Permanent
- Full-time
- 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/sign translation change request
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents
- Assist with 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
- 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
- Develop country and site budgets (including Split site budget)
- Tracking, and reporting of negotiations
- Maintenance of tracking tools
- Contract development, negotiation, approval and maintenance (e.g. CTRAs)
- Update and maintain contract; templates (in cooperation with Legal Department)
- Payment calculation and execution (investigators, vendors, grants)
- Ensure compliance with financial procedures
- Monitor and track adherence and disclosures,
- Budget closeout.
- Organize meetings (create & track study memos/letters/protocols)
- Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
- B.A./B.S. (Life Science preferred) or equivalent healthcare experience
- Minimum 1-2 years in Clinical Research or relevant healthcare experience
- Fluent in Local Languages and business proficient in English (verbal and written} and excellent communication skills
- Must be bilingual in French
- 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 appl1cations on computer) and ability to adapt to new IT applications; Strong MS Excel skills required.
- ICH-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 solution
- Must be able to go on site to sponsor office 2 days a week
- Eligible to work in Canada without visa sponsorship