Director/Mgr. of Clinical Research Ops

Job Title: Director/Mgr. of Clinical Research Ops

Work Location: Miami-Dade County, Florida

Summary:

Seeking an experienced leader to oversee early phase clinical research operations at a high-volume site. This role focuses on managing staff, ensuring protocol compliance, and maintaining operational excellence in clinical trials. The position requires strong leadership, regulatory knowledge, and the ability to drive quality and efficiency in clinical operations.

Responsibilities:

• Lead and mentor clinical operations staff to foster a collaborative and high-performing team environment.
• Ensure strict adherence to clinical trial protocols and maintain high-quality standards throughout all studies.
• Collaborate with investigators and site leadership to assign studies and develop effective patient enrollment strategies.
• Oversee human resources functions, including staff recruitment, training, and performance evaluations.
• Monitor protocol compliance, promptly reporting deviations to appropriate regulatory bodies.
• Coordinate assignment of primary clinical research coordinators for each study in partnership with site leadership.
• Review study requirements with investigators and leadership, clarifying any issues prior to study initiation.
• Conduct study closeout procedures and adapt to evolving operational needs as required.

Qualifications:

• Bachelor's degree in a scientific or healthcare-related field.
• 7-10 years of experience in clinical operations, with at least 5 years in a senior leadership role.
• Experience in early phase (Phase I) clinical research and high-volume site operations.
• Strong understanding of FDA, ICH, and GCP regulations and guidelines.
• Demonstrated ability to manage, mentor, and develop clinical operations teams.
• Excellent communication, organizational, and leadership skills.
• Proficiency in Microsoft Word, Excel, and clinical management software.
• Ability to travel as needed.
• Comprehensive knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out.

Published Category: Clinical Operations & Development