Clinical Research Coordinator
Visionary Eye Doctors
Rockville, MD (In Person)
Full-Time
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Job Description
Position Summary The Clinical Research Coordinator supports the day-to-day coordination of ophthalmology clinical trials conducted under IRB-approved protocols and in accordance with Good Clinical Practice guidelines. This role assists with study visits, regulatory documentation, sponsor communication, data entry, and overall study organization across active research protocols. Primary Responsibilities Clinical Trial Coordination Coordinate day-to-day activities for active ophthalmology clinical trials, registries, and investigator-initiated studies Schedule and manage subject visits in accordance with protocol requirements Support subject screening, eligibility review, and follow-up visit coordination Assist with informed consent documentation and study visit preparation Regulatory Documentation and Compliance Maintain study binders and essential regulatory documents for active and archived studies Prepare and organize regulatory documents for sponsors, CROs, and IRBs Track protocol amendments, training records, delegation logs, and study correspondence Support preparation for sponsor monitoring visits and audits Data Entry and Study Documentation Perform electronic data entry in sponsor-required databases and electronic data capture systems Maintain source documentation and assist with data query resolution Ensure study documentation is complete and organized according to protocol requirements Sponsor and Site Communication Serve as a point of contact for sponsors, CROs, and research vendors for study-related communication Coordinate monitoring visit logistics and follow-up items Assist with sponsor document requests and study deliverables Clinical Collaboration Coordinate with physicians, technicians, and clinic staff to support research visits and protocol procedures Assist with integration of research activities into clinic workflow Preferred Qualifications Bachelor's degree in health sciences, biological sciences, or related field, or equivalent relevant work experience 1-3 years of clinical research coordination experience preferred; ophthalmology or device trial experience strongly preferred Familiarity with Good Clinical Practice (GCP), informed consent procedures, and IRB-regulated research Experience maintaining regulatory documentation and coordinating study visits Strong organizational skills, attention to detail, and ability to manage multiple concurrent tasks in a clinical setting Technical Skills Proficiency with Microsoft Office Suite, including Excel, Word, and Outlook Experience with electronic medical record systems and clinical documentation workflows Familiarity with electronic data capture platforms used in clinical research (e.g., REDCap, Veeva EDC, CASTOR, or similar systems) Ability to manage electronic regulatory files, study trackers, and sponsor correspondence Benefits Health insurance Dental Insurance Life Insurance Accidental Death & Dismemberment Insurance 401(K) PTO and holidays off Career growth and development
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