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Clinical Research Project Coordinator
hace 2 meses
Role Overview: The Clinical Trial Coordinator is responsible for ensuring the effective management of clinical trial activities, maintaining high standards of quality and compliance.
Key Responsibilities:
- Conduct thorough reviews of departmental, internal, country, and investigator files, documenting findings in the designated systems.
- Ensure timely completion of assigned tasks, adhering to budget constraints and maintaining quality standards.
- Proactively communicate potential risks to project leads to facilitate timely decision-making.
- Assist in the upkeep of study-specific documentation and systems, including tracking project-specific training requirements and managing system access.
- Provide support for systems such as GoBalto and eTMF.
- Contribute to Risk-Based Monitoring (RBM) activities.
- Perform administrative duties related to assigned trials, including processing documents for the Client's electronic Trial Master File (eTMF) and conducting reviews.
- Coordinate scheduling for client and internal meetings.
- Review and monitor local regulatory documents to ensure compliance.
- Facilitate the transmission of documents to clients and centralized Institutional Review Boards (IRB) or Independent Ethics Committees (IEC).
- Analyze and reconcile study metrics and findings reports to support project objectives.
- Assist in clarifying and resolving discrepancies related to site documentation.
- Maintain trackers for vendor activities.
- Support the coordination, compilation, and distribution of Investigator Site Files (ISF) and Pharmacy binder materials.
- Assist with translation materials and quality control upon request.
Additional Responsibilities:
- Provide administrative support for site-initiated amendments and manage site supply shipments.
- Oversee courier management for trial-related documents.
- Support Clinical Research Associates (CRAs) in preparation for site visits.
- Assist Clinical Trial Managers (CTMs) and Project Managers (PMs) with country project-related expenditures.
- Facilitate the distribution of country and site-level communications.
- Create and maintain an updated investigator list.
- Ensure quality control of country and site-level documents.
- Submit complete country and site-level documents to the eTMF and track them in the Clinical Trial Management System (CTMS).
- Monitor document tracking in CTMS, verifying the application of appropriate activity plans for countries or sites.
- Compile and distribute Investigator Site Files (ISF) and Pharmacy binders prior to Site Initiation Visits (SIV).
- Review eTMF reports and dashboards to assess the status of essential documents at the country and site levels.
- Follow up on outstanding or missing study documents to ensure timely submission.
- Manage the forwarding of physical documents retrieved from sites.