Clinical Trial Coordinator

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ij1tn

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Dopo aver letto questa descrizione, invii il suo CV e le eventuali informazioni aggiuntive richieste facendo clic sul pulsante di candidatura.

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office
Job Description

What You'll Do

Clinical Trial & Documentation Support

Coordinate and complete assigned clinical trial activities in accordance with the study task matrix.
Perform Country and Investigator file reviews and document findings in the appropriate systems.
Support audit and inspection readiness by ensuring study files are reviewed according to applicable schedules and procedures.
Ensure assigned activities are completed on time and to a high-quality standard, proactively communicating potential risks to project leads.
Process and maintain clinical trial documentation within the electronic Trial Master File (eTMF).




Review eTMF documentation and support the resolution of missing, incomplete, or outstanding documentation.
Analyze findings reports and assist with the clarification and resolution of site documentation findings.
Support the preparation, compilation, and distribution of Investigator Site Files (ISFs), pharmacy binders, and study supplies.
Assist with study-specific translations and translation quality control, as required.
Site Activation & Regulatory Support

Provide administrative support for site activation and start-up activities.
Work with internal teams to help ensure site start-up activities remain aligned with the site's activation critical path and project timelines.
Support regulatory submissions and the tracking of local regulatory documentation.
Transmit required documentation to clients and centralized Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), as applicable.
Maintain accurate and timely records of

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ij1tn