Permanent opportunity for a Manager/Director of Clinical Operations, Phase I, to oversee clinical trials and managing both staff and operational aspects of studies.
- Phase I or early phase experience
- Bi-lingual in English and Spanish
- Site level
Responsibilities:
- Lead and mentor the clinical operations team to promote a collaborative and efficient environment.
- Ensure protocol compliance and maintain high-quality standards across studies.
- Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.
- Oversee human resources functions, including staff evaluations, recruitment, and training.
- Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies.
- Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators.
- Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation.
- Conduct study closeout procedures.
Minimum Qualifications:
- Bachelor's degree in a scientific or healthcare-related field
- 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.
- In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out
- Experience managing and mentoring a team of clinical operations professionals