Senior Clinical Research Coordinator
hace 1 mes
About the Role:
We are seeking a highly skilled and experienced Senior Clinical Research Coordinator to join our team at Thermo Fisher Scientific. This role will be responsible for coordinating clinical trials, ensuring timely completion of tasks, and maintaining high-quality standards.
Key Responsibilities:
- Perform department, internal, country, and investigator file reviews as assigned and document findings in appropriate systems.
- Ensure allocated tasks are performed on time, within budget, and to a high-quality standard.
- Proactively communicate any risks to project leads.
- Support the maintenance of study-specific documentation and systems, including but not limited to: study team lists, tracking of project-specific training requirements, system access management, and tracking of project-level activity plans in appropriate systems.
- Provide system support (GoBalto & eTMF).
- Support RBM activities.
- Perform administrative tasks on assigned trials, including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Support scheduling of client and/or internal meetings.
- Review and track local regulatory documents.
- Transmit documents to client and centralized IRB/IEC.
- Analyze and reconcile study metrics and findings reports.
- Assist with clarification and resolution of findings related to site documentation.
- Maintain vendor trackers.
- Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assist with study-specific translation materials and translation QC upon request.
Additional Responsibilities:
- Provide administrative support for site-initiated amendments and site supply shipments.
- Manage couriers.
- Support CRAs in visit preparation.
- Support CTMs/PMs in country project-related expenditures.
- Assist in translation and translation QC.
- Distribute country and site-level communications.
- Create and maintain investigator list.
- QC of country and site-level documents.
- Submission of complete country and site-level documents to eTMF and related tracking in CTMS.
- Perform document tracking in CTMS, verify appropriate country or site-level activity plans are applied, update country-level activities/documents for amendments.
- Compile and distribute Investigator Site File (ISF) and Pharmacy binder to site prior to SIV.
- Review eTMF reports and Preclarus dashboards to identify country and site-level essential documents statuses.
- Follow up on outstanding/missing study documents to be sent to site.
- Forward 'wet ink' documents retrieved from sites.
What We Offer:
We offer a competitive salary range of $70,000 - $90,000 per annum, based on experience and qualifications.
About Us:
Thermo Fisher Scientific is a world leader in serving science, with a commitment to innovation and customer satisfaction. Our company offers a dynamic work environment, opportunities for growth and development, and a comprehensive benefits package.
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