Clinical Research Site Manager
Medix™ · San Juan
Descripcion del puesto
About the role
We are seeking a Clinical Research Site Manager to lead day‑to‑day operations at a well‑established clinic that runs clinical trials across multiple therapeutic areas. The role will oversee the clinical research team, ensure studies are conducted safely, efficiently and in full compliance with ICH‑GCP, FDA regulations and company policies.
Key responsibilities
- Lead and support clinical research teams to achieve study performance, operational efficiency, patient safety and regulatory compliance.
- Collaborate with Business Development, Patient Recruitment, Finance, Budgets & Contracts and Quality to meet timelines, enrollment targets and budget expectations.
- Monitor study progress using dashboards and clinical systems, ensuring timely execution of site and patient activities.
- Oversee staffing, site assignments and team performance, escalating operational or quality risks as needed.
- Facilitate onboarding and ongoing training on protocols, SOPs, CRF completion and study requirements.
- Ensure adherence to GCP, FDA regulations, SOPs, HIPAA and internal policies.
- Manage staff performance, scheduling, hiring, coaching and professional development.
- Partner with investigators and site personnel to support successful study execution and patient safety.
Required profile
- Bachelor’s degree or equivalent experience.
- Minimum 2 years experience as a Clinical Research Coordinator.
- At least 2 years of overall clinical research experience.
- Prior management experience in clinical research preferred.
- Bilingual English/Spanish is a plus.
Required skills
- Proficiency with Microsoft Office.
- Experience using electronic health record (EHR) systems.
- Comfort with web‑based applications and clinical data platforms.
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Publicado hace 22 horas
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Medix™
San Juan
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