Clinical Research Coordinator – Retina Clinical Trials

Advanced Retina Institute is seeking a detail-oriented, dedicated Clinical Research Coordinator (CRC) to join our growing clinical trial team in Bonita Springs, FL. In this role, you will manage day-to-day study operations in compliance with study protocols, Good Clinical Practice (GCP), and federal regulatory guidelines.

We are actively seeking candidates from any of the following backgrounds:

• Experienced Clinical Research Coordinators (retina/ophthalmology experience preferred).
• Clinical Research Coordinators looking to specialize in retina (retina-specific training provided).
• Retina Technicians / Ophthalmic Assistants eager to transition into clinical trial management (comprehensive research coordinator training provided).

Key Responsibilities

Protocol & Patient Management

• Coordinate and manage retina clinical trials from study start-up through close-out.
• Screen, recruit, schedule, and retain trial participants according to protocol specifications.
• Facilitate and thoroughly document the informed consent process in accordance with federal guidelines (45 CFR Part 46).
• Conduct study visits, coordinating required ophthalmic assessments, diagnostic imaging, and physician procedures.

Data Integrity & Regulatory Compliance

• Maintain accurate, timely, and complete source documentation and Electronic Data Capture (EDC) entry.
• Manage regulatory files, including IRB submissions, approvals, amendments, safety reports, and continuing reviews.
• Report and track adverse events, protocol deviations, and safety updates in compliance with 21 CFR 312.
• Prepare for and participate in sponsor monitoring visits, audits, and regulatory inspections.

Clinical Operations & Lab Support

• Handle, store, track, and perform temperature monitoring for investigational products (IP).
• Collect, process, store, and ship biological laboratory specimens in accordance with protocol and IATA requirements.
• Ensure ophthalmic diagnostic equipment certifications, calibration, and maintenance logs are up to date.

Team Collaboration & Site Ownership

• Serve as the primary point of contact for sponsors, CRAs/monitors, investigators, and clinic staff.
• Assist with site feasibility assessments and initial study start-up activities.
• Train and support clinic staff on protocol-specific requirements as needed.
• Take full ownership of study timelines and deliverables, including occasional flexibility/after-hours work when required to meet strict protocol deadlines.

Qualifications & Requirements

Education & Experience (One of the following combinations required):

• Bachelor’s degree in a science or healthcare-related field (preferred), OR equivalent practical medical/research experience.
• 1 to 3 years of clinical research experience (retina experience preferred, but not required—we will train the right candidate).
• OR 2 years of Retina/Ophthalmic Technician experience with a strong desire to learn clinical research operations.

Knowledge & Skills:

• Working knowledge of FDA regulations, IRB requirements, and GCP guidelines.
• Strong verbal, written, and interpersonal communication skills.
• Intermediate to advanced computer skills (MS Office Suite, Web-based trial platforms, EHR systems).
• Excellent organizational abilities and high attention to detail in a clinical setting.
• Familiarity with retinal imaging modalities (OCT, Fundus Photography, Fluorescein Angiography) is a strong plus.

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• 401(k)
• Paid Time Off (PTO)
• Professional Development & Training Assistance

Benefits:

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

Work Location: In person