Phase I Clinical Operations Leader

Barrington James; Miami (FL); On-site; USD 180,000 - 240,000; Full time

Job summary

Barrington James is seeking a Director of Clinical Operations, Phase I, to oversee multiple studies and ensure protocol adherence. You will manage staff, review protocols, and assure quality across trials in alignment with FDA, ICH, and GCP requirements.

Responsibilities include leading the operations team, coordinating with PIs and Site Directors, and overseeing HR functions such as recruitment and training, while maintaining sponsor and regulatory communications.

Qualifications

• Bachelor's degree in a scientific or healthcare field.
• Phase I or early phase clinical trial experience.
• 7–10 years in clinical operations with 5+ years in a senior leadership role.
• Strong knowledge of FDA, ICH and GCP regulations.
• Excellent communication, organizational and leadership skills.
• Proficiency with Microsoft Word, Excel and clinical trial software.
• Experience mentoring a clinical operations team.
• Fluent in English and Spanish.

Responsibilities

• Lead and mentor the clinical operations team.
• Ensure protocol compliance and quality across studies.
• Partner with PIs and Site Director on study assignments and enrollment.
• Oversee HR tasks including evaluations, recruitment, and training.
• Monitor protocol adherence and report deviations to sponsors/regulators.
• Coordinate with Site Director to assign coordinators.
• Review study components with PIs and Site Directors before start.
• Conduct study closeout procedures.
• Ensure FDA, ICH, and GCP compliance.

Skills

Leadership

Communication

Staffing

Project management

Regulatory knowledge

Bi-lingual English/Spanish

Education

Bachelor's degree in science/healthcare

Tools

Clinical trial management software

MS Word & Excel

Job description

Barrington James is seeking a Director of Clinical Operations, Phase I, to oversee multiple studies and ensure protocol adherence. You will manage staff, review protocols, and assure quality across trials in alignment with FDA, ICH, and GCP requirements.

Responsibilities include leading the operations team, coordinating with PIs and Site Directors, and overseeing HR functions such as recruitment and training, while maintaining sponsor and regulatory communications.