Summary

The Department of Ophthalmology is seeking a Research Coordinator II to support our growing clinical research mission. The Research Coordinator II independently coordinates and manages clinical research studies under the guidance of the Principal Investigator and departmental leadership. The position serves as the liaison between investigators, sponsors, participants, and support services to ensure protocol compliance, participant safety, data integrity, and achievement of study milestones. Duties include recruitment and retention, regulatory, visit coordination, data collection and management, sponsor interactions, monitoring visits, and maintenance of essential study documents. Strong organizational, communication, and project management skills are required to successfully manage multiple studies.

The Department of Ophthalmology Clinical Research program conducts industry-sponsored, investigator-initiated, and collaborative ophthalmic clinical trials. Coordinators perform participant screening, informed consent, enrollment, scheduling, source documentation, regulatory submissions, data entry, specimen processing, sponsor communications, and monitoring visit preparation. 

The position requires coordination of specialized ophthalmic procedures including visual acuity testing, OCT imaging, fundus photography, autofluorescence imaging, visual function testing, and other protocol-specific evaluations. The coordinator works closely with investigators, sponsors, imaging personnel, ancillary departments, and research participants to ensure protocol compliance and successful study conduct.

Job Duties

• Screens, recruits, enrolls, and consents research participants according to protocol requirements.
• Explains study procedures and educates participants regarding research study expectations and requirements.
• Schedules and coordinates study visits, laboratory testing, imaging procedures, and specialty evaluations.
• Coordinates participant follow-up visits and maintains participant retention throughout the study duration.
• Collects, processes, ships, and maintains documentation for blood and other biological specimens in accordance with protocol requirements.
• Collects patient information and maintains accurate source documentation and research records.
• Enters and maintains study data in EDC systems, databases, and institutional systems.
• Maintains regulatory files, study binders, delegation logs, essential documents, and training records.
• Prepares and submits Institutional Review Board (IRB) applications, amendments, continuing reviews, reportable events, and study closure documentation.
• Coordinates site initiation, interim monitoring, audit, and closeout visits and responds to sponsor and monitor requests.
• Communicates with sponsors, CROs, investigators, research staff, and ancillary departments regarding study activities and requirements.
• Tracks protocol compliance, study timelines, enrollment goals, and outstanding action items.
• Assists with investigational product and device accountability as required by protocol.
• Ensures compliance with BCM policies, FDA regulations, ICH-GCP guidelines, sponsor requirements, and applicable regulatory standards.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• One year of relevant experience.

Preferred Qualifications

• Ophthalmology or clinical research experience.
• Experience coordinating industry-sponsored clinical trials.
• Experience with IRB submissions and regulatory documentation.
• Experience using electronic data capture systems and CTMS platforms.
• CCRP or ACRP certification preferred.
• Ability to manage multiple clinical trials simultaneously.