Clinical Research Coordinator
hace 7 días
This position is a key support role to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
As a Site Management Associate I at PSI CRO AG, you will be responsible for:
- Serving as the primary site's contact point for vendors, study supplies, and access management.
- Ensuring that pre-study testing of local site facilities is completed.
- Assisting monitors in completing subject event and site event information in CTMS.
- Tracking the resolution status of site issues and action items in CTMS.
- Managing the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
You will also ensure regulatory and ethics committee submissions and notifications, requiring knowledge of local regulations and dispositions.
Responsibilities- Coordinate preparation for and follow-up on site, TMF and systems' audits and inspections.
- Manage the TMF on a site and a country level regularly and file documents.
- Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
- Arrange and track initial and on-going project training for site teams in all vendor-related systems.
- Document Management and translations status review of the study.
We are seeking a candidate with:
- A 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.
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