Clinical Trial Coordinator
2 semanas atrás
At Thermo Fisher Scientific, we're dedicated to making a positive impact on a global scale. As a Clinical Trial Coordinator, you'll play a vital role in bringing our mission to life by enabling our customers to make the world healthier, cleaner, and safer.
Our global Clinical department is a dynamic team of colleagues with a deep understanding of institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays, and complete high-quality, cost-efficient clinical studies.
Key Responsibilities:- Coordinate, oversee, and complete functions on assigned trials activities detailed on the task matrix.
- Perform department, internal, country, and investigator file reviews as assigned and document findings in the appropriate system.
- 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 the appropriate system.
- 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.
- High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
- Bachelor's degree preferred.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - integrity, intensity, innovation, and involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.
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