Job Title

As a Clinical Trial Coordinator you will be joining the worlds 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