Clinical Trial Coordinator
Há 5 dias
Supports the Project Team in providing administrative and technical assistance for clinical trials. Ensures audit readiness by reviewing files according to the organization's SOP and department guidance document. Provides administrative support for site activation activities, including developing the critical path for site activation within assigned projects. May represent CRG personnel, utilizing local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists suitable for feasibility activities and site tiering. Additionally, may act as a buddy during the onboarding phase and provide training to new staff as needed.
A Day in the Life:
- Coordinates, oversees, and completes functions on assigned trial activities as detailed on the task matrix.
- Performs department, internal, country, and investigator file reviews as assigned, documenting findings in appropriate systems.
- Ensures allocated tasks are performed on time, within budget, and to a high-quality standard, proactively communicating any risks to project leads.
- Provides system support, ensuring system databases are current, and performs administrative tasks on assigned trials, including timely processing of documents sent to the Client (e)TMF, performing (e)TMF reviews, distributing mass mailings, and communicating as needed.
- Analyzes and reconciles study metrics and findings reports, assists with clarification and resolution of findings related to site documentation, and assists with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request, maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided, and conducts on-site feasibility visits (APAC only), when applicable.
About the Role:
This role is part of Thermo Fisher Scientific's Clinical Operations team, supporting the delivery of clinical trials. The ideal candidate will have excellent organizational and communication skills, with the ability to work effectively in a team environment. If you are a detail-oriented and results-driven individual, this may be the opportunity for you.
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