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
