Clinical Research Coordinator

Essential Functions

Trial and site administration:

• 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

Document management:

• Prepare documents and correspondence o 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. o Prepare Investigator trial file binders o Execute eTMF Quality Control Plan
• Obtain translations of documents

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
• 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 country and site budgets (including Split site budget)
• Tracking, and reporting of negotiations
• Maintenance of tracking tools o 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) o Ensure compliance with financial procedures
• Monitor and track adherence and disclosures,
• Budget closeout.

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

Requirements:

• Minimum 1-2 years in Clinical Research or relevant healthcare experience
• B.A./B.S. (Life Science preferred) or equivalent healthcare experience
• Strong experience implicated in FCPA process and payments.
• Experience in regulatory field in an advantage.
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• 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