Job Summary RSM Vision Research is seeking a Full-Time Research Coordinator to manage clinical trial activities in compliance with ICH-GCP guidelines and protocol requirements. The Research Coordinator will oversee patient visits, regulatory documentation, and trial data collection for Phase I-IV ophthalmic clinical trials.
Coordinate daily clinical trial activities, schedule participant visits, conduct screening against inclusion/exclusion criteria, and lead or secondary-review the informed consent process (including ICF amendments).
Data & Trial Documentation:
Collect clinical data, complete questionnaires (e.g., VFQ), enter data into Electronic Data Capture (EDC) systems, manage source documents, and resolve sponsor/monitor queries within required timelines.
Ophthalmic Imaging & Procedures:
Perform and maintain certification for study imaging (OCT, OCTA, FA, FAF, CFP on Heidelberg, Optos, Cirrus, MAIA) and submit images to sponsors within 1-2 days (same-day for screening). Perform blood draws, IV infusions for FAs, and lab specimen collections per protocol.
Safety & Regulatory Oversight:
Track, log, and report Adverse Events (AEs), Serious Adverse Events (SAEs), and SUSAR/Safety reports to the sponsor and IRB. Maintain all regulatory files in the Investigator Site File (ISF).
Site Operations & Monitoring:
Order and maintain study supplies (lab kits, shippers), assist with monitor site visits, participate in teleconferences/Investigator Meetings, and ensure staff training on protocols is fully documented. Advanced Responsibilities (Level II): Act as primary coordinator for multi-site studies, mentor/train research assistants and junior coordinators, perform in-depth record reviews for SAEs, and utilize Clinical Trial Management Systems (CTMS) for reporting.
Qualifications Experience:
1-3+ years of clinical research experience (or prior Research Assistant/Coordinator roles).
Certifications Required:
ICH-GCP and IATA certifications, Phlebotomy.
Certifications Preferred:
SOCRA (CCRP) or ACRP (CCRC) certification.
Knowledge & Skills:
Working knowledge of eye anatomy, ocular diseases, and ophthalmic medications. Experience with CTMS and EDC platforms.
Physical Needs:
Manual dexterity for ophthalmic imaging equipment and capability to perform blood draws/IV infusions.
Pay:
From $15.00 per hour
Benefits:
401(k) Dental insurance Health insurance Life insurance Paid time off Parental leave Retirement plan Vision insurance Application Question(s): Does your background include hands-on clinical tasks (such as phlebotomy, ECGs, vital signs, and lab specimen processing) along with administrative/regulatory duties? Ability to
Relocate:
Hattiesburg, MS 39402: Relocate before starting work (Required) Willingness to travel: 25% (Preferred)
