Clinical Trial Specialist

SOUTHEASTERN RETINA ASSOCIATES PC•Johnson City, TN

2d•Onsite

About The 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.

Requirements

Familiarity with clinical trial regulations (FDA, ICH-GCP) required.
Strong interpersonal, multitasking, and documentation skills.
Proficiency with EDC platforms and Microsoft Office Suite.

Nice To Haves

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.

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.