Clinical Trial Coordinator I

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/881ke8

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description
THE CLINICAL TRIAL COORDINATOR I ROLE
The Clinical Trial Coordinator (CTC) I assists the clinical research team, supporting Project Managers (PMs), Study Start-up team, Clinical Research Associates (CRAs), and clinical sites to ensure studies are conducted in accordance with ICH GCP, applicable laws, SOPs, and the protocol in respect of study budget and timelines.

ESSENTIAL JOB FUNCTIONS
• Responsible (in collaboration with PM, CRAs, and Study Start-up team, as applicable) for site identification and feasibility, including initial site outreach, follow-up,



and circulation and collection of feasibility questionnaires and Non-disclosure Agreements (NDAs)
• Supports PM with the management of and participation in internal, client/sponsor, scientific, and other meetings as required, including but not limited to supporting with scheduling meetings and preparing agendas and meeting minutes
• Responsible (under PM oversight and in collaboration with Study Start-up team, as applicable) for site start-up activities, including Ethics Committees and Institutional Review Boards and Regulatory submissions (at site, national, and international level, as applicable) and site contract and budget negotiation
• Maintains relationships with Ethics Committees (ECs) and Competent Authorities (CAs), as applicable
• Responsible for document management including Trial Master File (TMF) setup maintenance and TMF QC (under PM oversight)
• Supports PM with Investigator Site File (ISF) pr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/881ke8