FSP Clinical Trial Coordinator II – East Coast

Work Schedule Environmental Conditions Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life — enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life‑changing therapies.

With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on — now and in the future.

Purpose of the position

• Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
• Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
• Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU)
• Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH‑GCP, Company policy and procedures. Includes liaison with service providers in regard to the e‑TMF process and resolving issues related to missing documentation
• Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection
• Contributes to clinical trial excellence initiatives

Main responsibilities and tasks Be responsible for setting‑up, monitoring verifying and archiving the clinical Trial Master File (TMF)

• In charge of the electronic TMF (and/or paper TMF, if applicable) set‑up and administration.
• Manage the clinical study creation and set‑up for the country and site binders and the trial milestones.
• Prepare and customise the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners.
• Inform the appropriate role of all study team members (CRO) newcomers or departure.
• Ensure the TMF is being maintained up‑to‑date and all essential documents are appropriately filed in the TMF.
• Perform continuous oversight of the CRO TMF activities, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant the study team members.
• Coordinate the TMF Quality Check (per client SOP) with the CRO to ensure the eTMF inspection readiness.
• Coordinate the final TMF reconciliation with the CRM/CPM.
• In charge of archiving the TMF

Be responsible for follow‑up and review of financial documents, in collaboration with CRM/CPM

• Create and update financial information within the financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team
• Create and follow‑up of the clinical study Commitment Requests within the dedicated tool (K2)
• Create and update the specific clinical study budget trackers
• Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM
• Follow up of the clinical study invoices to secure payments in time. Support, if necessary, the CRM/CPM in the clinical study budget such as forecast preparation, attendance to quarterly review meetings.

Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)

• Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect)
• Ensure the complete data tracking by the CROs…