Clinical Trials Operations Lead

Bay Area Retina Associates; Walnut Creek (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Bay Area Retina Associates in Walnut Creek, CA, seeks a Clinical Research Supervisor to oversee the clinical trials unit, collaborate with physicians, and ensure patient safety and protocol compliance. This role directs the CTU team, manages onboarding, budgeting, and billing, and serves as a back-up for study activities.

The candidate will lead regulatory documentation, supervise coordinators, and uphold GCP standards while coordinating with the Clinical Research Manager and Operations

Qualifications

• 4 years of Clinical Research experience and knowledge of regulations.
• Phlebotomy certification and ophthalmology clinical research experience preferred.

Responsibilities

• Oversee onboarding of new studies and manage budgets.
• Lead CTU staff and coordinate weekly meetings.
• Manage invoicing, billing, and study payments.
• Ensure regulatory binders and ISF are up to date.
• Coordinate patient visits, screenings, and informed consent per ICH/GCP.
• Maintain data integrity in EDC and source documents.
• Travel to study sites as needed.

Skills

Clinical Research

Regulatory compliance

Team supervision

Budget management

Education

Bachelor's degree

Tools

Microsoft Office

EDC

Job description

Bay Area Retina Associates in Walnut Creek, CA, seeks a Clinical Research Supervisor to oversee the clinical trials unit, collaborate with physicians, and ensure patient safety and protocol compliance. This role directs the CTU team, manages onboarding, budgeting, and billing, and serves as a back-up for study activities.

The candidate will lead regulatory documentation, supervise coordinators, and uphold GCP standards while coordinating with the Clinical Research Manager and Operations