Phase I Clinical Operations Director

Barrington James Limited; Town of Florida (NY); On-site; USD 150,000 - 230,000; Full time

Job summary

Barrington James Limited is seeking a Director of Clinical Operations, Phase I, to oversee clinical trials, ensure protocol adherence, and manage staff and operational aspects of studies. The role emphasizes strong leadership, regulatory compliance, and collaboration with investigators.

The position requires 7–10 years in clinical operations with 5+ years in a senior leadership role, and bilingual English/Spanish capabilities to support multinational studies.

Qualifications

• Bachelor’s degree in a scientific or healthcare field is required.
• Phase I or early phase experience is required.
• 7–10 years of clinical operations experience with 5+ years in a senior leadership role.
• Strong understanding of FDA, ICH and GCP regulations and guidelines.
• Proven leadership, communication, and organizational skills.
• Experience with staff mentoring and recruitment processes.

Responsibilities

• Lead and mentor the clinical operations team to ensure efficient trials.
• Ensure protocol compliance and high quality standards across studies.
• Partner with PIs and Site Directors to assign studies and develop enrollment strategies.
• Oversee HR functions including staff evaluations, recruitment and training.
• Monitor protocol adherence and report deviations to sponsors and regulators.
• Coordinate with Site Director and PIs to assign coordinators.
• Review study components with PIs and Site Directors before initiation.
• Conduct study closeout procedures.
• Ensure compliance with FDA, ICH and GCP regulations.

Skills

Leadership

Staff management

Clinical operations

Study start-up

GCP compliance

FDA regulations

Communication

Spanish language

Mentoring

CTMS / EDC

Education

Bachelor's degree in a scientific or healthcare field

Tools

CTMS

EDC systems

Microsoft Word/Excel

Job description

Barrington James Limited is seeking a Director of Clinical Operations, Phase I, to oversee clinical trials, ensure protocol adherence, and manage staff and operational aspects of studies. The role emphasizes strong leadership, regulatory compliance, and collaboration with investigators.

The position requires 7–10 years in clinical operations with 5+ years in a senior leadership role, and bilingual English/Spanish capabilities to support multinational studies.