Clinical Trial Specialist

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:

• Only full-time employees eligible

Benefits:

• Health insurance
• Dental insurance
• Vision insurance
• Retirement plan
• Paid time off

Schedule:

• Monday to Friday
• Day shift
• 8 hour shift

Work Remotely

• No