Clinical Research Coordinator, Ophthalmology

Overview of Role The Department of Ophthalmology, is looking for a clinical research coordinator who plays a vital role in supporting and advancing clinical research focused on retinal diseases and therapies. This position is responsible for coordinating and managing retina-related clinical studies from initiation to close-out, ensuring strict adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Roles and Responsibilities Plan, coordinate, and execute clinical trials, including site selection, subject recruitment, and data management. Ensure compliance with relevant regulations, such as the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), FDA regulations, and institutional review board (IRB) guidelines. Collaborate with investigators, research coordinators, and other stakeholders to ensure successful study outcomes. Develop and maintain detailed study protocols, case report forms, and informed consent documents. Coordinate and manage study-related activities, including subject visits, data collection, and data quality control. Ensure accurate and timely reporting of study results, including adverse event reporting. Maintain accurate and up-to-date records of all study-related activities, including participant enrollment, data collection, and study close-out. Participate in investigator meetings, site initiation visits, and other study-related meetings as required. Develop and maintain relationships with investigators, research coordinators, and other stakeholders to ensure successful study outcomes. Provide education and training to research staff on Good Clinical Practice (GCP), regulatory requirements, and study protocols. Coordinate and manage the distribution of study materials, including participant information sheets, informed consent forms, and case report forms. Ensure compliance with institutional policies and procedures related to clinical trials. Participate in quality assurance activities, including audits and inspections, to ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. Maintain confidentiality and handle sensitive or confidential information with discretion. Perform other duties as assigned by the department.