Clinical Research Coordinator

Position Summary        *This is not a remote position*

Southeastern Retina Associates (SERA) is seeking a highly organized and detail-oriented Clinical Research Coordinator to support our robust portfolio of clinical trials focused on sight-saving treatments. This position plays a vital role in ensuring quality data collection, regulatory compliance, and patient safety in coordination with our physicians and research teams. We are a growing visionary clinical trials department leading the way in gene therapy.

Essential Duties & Responsibilities

• Maintain a thorough understanding of each assigned clinical trial protocol, including objectives, endpoints, and regulatory context.
• Coordinate informed consent processes per GCP guidelines, ensuring patient comprehension and appropriate documentation.
• Monitor regulatory documents (e.g., Form 1572, delegation logs) for accuracy and completeness before study initiation.
• Provides guidance to ancillary staff (e.g., photographers, OCT techs, BCVA-certified personnel, front office, masked/unmasked staff) to ensure protocol adherence and timely task execution. Communicates with them proactively throughout the study.
• Collaborate with the Screening Department to develop and process screening packets within enrollment timelines.
• Screen, enroll, and retain eligible patients in assigned studies while monitoring for protocol compliance and safety signals.
• Educate subjects about protocol changes, risks, and updated informed consent forms.
• Maintain accurate, timely source documentation and electronic CRFs per protocol and SOPs.
• Conduct chart reviews and patient outreach to boost study recruitment; respond to internal and external referrals within 24 hours.
• Communicate proactively with sponsors, CROs, and monitors (CRAs, medical monitors) to resolve queries and complete action items.
• Transport or coordinate pick-up of biological specimens as required by protocol.
• Participate in study monitoring visits and audits with professionalism and accuracy.
• Cross-cover for other research coordinators and assist with telephone screening as needed.
• Maintain awareness of and compliance with FDA, ICH-GCP, and institutional regulatory standards for clinical research.
• Travel between SERA locations if needed and work overtime when necessary.
• Perform additional duties as assigned to support the research team and overall patient care mission.

Physical & Cognitive Demands

• Frequent walking and standing throughout the day to assist patients and support physician activities.
• Able to lift/move items >15 lbs (e.g., supplies, specimens).
• Frequent use of hands for fine motor tasks, such as operating equipment and documentation.
• Must be comfortable working in low-light exam environments and possess full spectrum visual acuity (corrected or uncorrected).
• Comfortable guiding and physically supporting patients with low vision.
• Verbal communication skills to support patient education and coordination with clinical teams, sponsors, and study staff.
• Occasional stooping, kneeling, or crouching in exam and procedure rooms.
• Ability to sustain attention to detail, maintain data integrity, and document precisely in a fast-paced environment.

Qualifications

• Associate or bachelor’s degree in health sciences or related field preferred.
• Prior experience in ophthalmology or clinical research strongly preferred.
• Certified Clinical Research Coordinator (CCRC) or willingness to obtain certification encouraged.
• Familiarity with clinical trial regulations (FDA, ICH-GCP) required.
• Strong interpersonal, multitasking, and documentation skills.
• Proficiency with EDC platforms and Microsoft Office Suite.

Job Type: Full-time