Legal & Regulatory Coordinator

6 days ago


Kirkland QC, Canada ICON Strategic Solutions Full time

As a Clinical Trial Coordinator you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Clinical Trial Coordinator (CTC)

Trial and site administration:
Update clinical trial databases (CTMS) and trackers
Collate, distribute/ship, and archive clinical documents, e.g. eTMF
Assist with eTMF reconciliation
Execute eTMF Quality Control Plan
Regulatory & Site Start-Up responsibilities: In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
Support preparation of submission package for IRB/ERC and support regulatory
Publish study results for GCTO and RA where required per local legislation
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. Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
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)

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./Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to
work within these guidelines.
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.
Excellent negotiation skills for CTCs in finance area
Effective communication with external customers (e.g. sites and investigators)
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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