Phase 1 Clin Res Director/Mgr. of Clinical Ops-Miami, FL

About the role

We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs.

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.
• Coincide 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.
• Perform additional duties as needed to adapt to the evolving needs of CPMI.
• Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP

Requirements

• 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.
• Strong understanding of FDA, ICH, and GCP regulations and guidelines
• Strong communication, organizational, and leadership skills.
• Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software.
• In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out

Qualifications

• Phase I or early phase experience
• Bi-lingual in English and Spanish