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Clinical Research Site Manager
hace 2 meses
Job Summary
PSI is seeking a highly skilled Clinical Research Site Manager to join our international team. As a key support to clinical research projects, you will be responsible for streamlining communication, maintaining systems, and managing documents and information.
Key Responsibilities
- Act as the primary point of contact between site personnel and CRA involved in the project, assisting with query resolution and EDC completion.
- Serve as the primary site's contact point for vendors, study supplies, and access management.
- Ensure that pre-study testing of local site facilities is completed, including scans, MRI/CT qualification questionnaires, test ECGs, etc.
- Assist monitors in completing all subject event and site event information in CTMS, tracking the resolution status of site issues and action items.
- Manage the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies.
- Ensure regulatory and ethics committee submissions and notifications, staying up-to-date on local regulations and dispositions.
- Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections.
- Manage the TMF on a site and country level, filing documents, preparing, distributing, and updating Investigator Site Files (ISF) and ISF checklists.
- Arrange and track initial and ongoing project training for site teams in all vendor-related systems.
- Document management and translations status review of the study.
- Ensure proper safety information flow with investigative sites.
Qualifications
- College/University Degree in Life Sciences.
- Administrative work experience, preferably in an international setting.
- Prior experience working as a CTA for CROs.
- Prior experience working in Clinical Research.
- Local regulations knowledge.
- Full working proficiency in English and Spanish.
- Proficiency in MS Office applications.
- Ability to plan and work in a dynamic team environment.
- Communication and collaboration skills.
Additional Information
As a Clinical Research Site Manager at PSI, you will have the opportunity to advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.