Bilingual Clinical Trial Coordinator - Finance

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
6 hours ago