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Clinical Trials Specialist
2 semanas atrás
We are seeking a skilled Clinical Trial Coordinator to join our team. In this role, you will play a crucial part in the success of our clinical trials.
Key Responsibilities:- Coordinate and perform department, internal, country, and investigator file reviews as assigned, documenting findings in appropriate systems.
- Ensure allocated tasks are performed on time, within quality standards, and proactively communicate any risks to project leads.
- Provide system support, ensuring system databases are current, and perform administrative tasks on assigned trials.
- Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution of findings related to site documentation.
- Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Maintain knowledge of SOPs, client SOPs/directives, and current regulatory guidelines applicable to services provided.
- Conduct on-site feasibility visits where applicable.
- Support scheduling of client and/or internal meetings.
- Review and track local regulatory documents.
- Provide system support and assist with RBM activities.
- Support the maintenance of study-specific documentation and systems.
In this role, you will work directly with sites to obtain documents related to site selection, assist the project team with regulatory compliance review packages, and provide support as needed to coordinate with internal departments.
Excellent communication and problem-solving skills are essential for this role. You must be able to work effectively in a team environment and maintain an efficient plan for site contact and follow-up.
We offer a dynamic and collaborative work environment that fosters growth and development. We are committed to providing our employees with the tools and resources necessary to succeed in their roles.
