Clinical Trial Coordinator (MSD)

Roles and Responsibilities

Responsibilities include, but are not limited to:
• Trial and site administration:
o Track (e.g. essential documents) and report (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
o Update manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Obtain translations of documents

 Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain and process FCPA documentation in a timely manner

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

Required Skills:

Accountability, Accountability, Analytical Problem Solving, Budget Management, Clinical Data Management, Clinical IT, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Data Analysis, Drug Regulatory Affairs, Financial Advising, ICH GCP Guidelines, Medical Risk Management, Medical Supply Management, Project Management, Public Administration, Regulatory Compliance, Site Management, Supply Change Management, Supply Management {+ 1 more}