Job Description
Position Summary
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.
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.
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.
Benefit Conditions:
Benefits:
Schedule:
Work Remotely
Job Type: Full-time
Work Location: In person
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