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Clinical Site Management Specialist
2 semanas atrás
Deliver exceptional site management and regulatory compliance as a Clinical Site Navigator.
This hybrid role combines start-up and iHCRA/CRA responsibilities to ensure seamless progression from feasibility to site activation, through maintenance phase as required.
- Coordinate site-level activities throughout the start-up phase of a clinical trial.
As the single point of contact for investigative sites, this role ensures robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
The ideal candidate has a scientific degree or clinical expertise, with strong knowledge of ICH guidelines and RA, IRB/IEC regulations. Experience in clinical development or start-up/regulatory process is also required.
Key responsibilities include:
- Oversight of site-level tasks associated with efficient site activation.
- Identifying potential research sites and assessing their capabilities and resources.
- Conducting initial site outreach, remote pre-study visits, and follow-up documentation.
- Supporting customization and translation of informed consent forms and patient-facing materials.
- Collecting, tracking, and performing quality reviews of essential documents required for effective and compliant study site activation.
- Participating in team meetings to progress trials and implement action plans for site-level risks.
- Ensuring Fortrea is audit-ready by completing accurate, timely, and consistent system compliance.
- Facilitating the preparation of research sites for patient enrollment.
- Performing CRF review and data validation against source documentation.
Responsibilities are diverse and require excellent time management skills to meet project deadlines.