Clinical Research Coordinator – Retina Clinical Trials

Position Summary
We are seeking a highly organized and detail-oriented Experienced Clinical Research Coordinator (CRC) to support clinical trials in retina and ophthalmology. The CRC will be responsible for the day-to-day coordination of clinical research studies in compliance with protocol requirements, Good Clinical Practice (GCP), and regulatory guidelines.

Key Responsibilities

• Coordinate and manage retina clinical trials from study start-up through close-out
• Screen, recruit, and consent study participants according to protocol requirements
• Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46)
• Schedule and conduct study visits, including coordination of ophthalmic assessments, imaging, and procedures
• Ensure accurate and timely collection, documentation, and entry of study data into electronic data capture (EDC) systems
• Maintain regulatory documentation, including IRB submissions, approvals, amendments, and continuing reviews
• Prepare for and participate in sponsor monitoring visits, audits, and inspections
• Ensure study conduct is compliant with GCP, institutional policies, and study protocols
• Coordinate investigational product handling, storage, accountability, and temperature monitoring
• Collect, process, and ship biological specimens in accordance with protocol and laboratory requirements
• Report and track adverse events and protocol deviations in a timely and accurate manner in accordance with the Federal Code of Regulations (21 CFR 312)
• Serve as a primary point of contact for sponsors, monitors, investigators, and study staff
• Assist with study feasibility assessments and site start-up activities
• Maintain organized and up-to-date study files and source documentation
• Provide training and support to clinic staff involved in research activities as needed
• Participate in team concepts and promote a team effort; performs duties in accordance with company policies and procedures
• Participate in staff meetings and trainings as required
• Take full ownership of assigned study responsibilities, ensuring all tasks are completed accurately and on time, including after-hours work when required to meet study deadlines
• Regular and reliable attendance is required for the job

Qualifications/Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Requirements include:

• Bachelor's degree in related field preferred.
• One (1) to three (3) years of experience in clinical research preferred
• Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice
• Prior experience coordinating ophthalmology or retina clinical trials preferred
• Familiarity with retinal imaging modalities (OCT, fundus photography, fluorescein angiography) preferred
• Strong verbal and written communication skills required
• Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools)

Pay: $25.00 - $32.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Vision insurance

Work Location: In person