Clinical Research Coordinator / Certified Ophthalmic ...

Apply for Job Job ID370919 LocationTwin Cities Job FamilyResearch Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8353CR Employee ClassCivil Service Add to Favorite Jobs Email this Job About the Job Position Summary: The Clinical Research Coordinator / Certified Ophthalmic Technician provides overall study management for research faculty on a variety of research studies to include business and industry studies, investigator-initiated studies and NIH sponsored research. This position reports to the Department Administrator. The research coordinator is a key member of the department's research team and responsibility will manage research projects across the adult ophthalmology program and will provide some back up support of the pediatric program. Troubleshooting and independent problem-solving skills will be important in this role. The position collaborates with other areas of the University to include Clinical Translational Science Institute (CTSI) clinical research services, and the staff in the Ophthalmology clinic and MHealth Fairview research clinic in assuring that studies meet regulatory requirements, policies and procedures are completed according to the study protocol. Major Duties/Job Description: Research Study Coordination (40%): Work closely with the Investigators in subject screening and recruitment, verifying subject eligibility, facilitating subject enrollments, and timely acquisition of research samples. Provide effective specimen management, including preparing kits, preparing shipments, tracking inventory, etc. Responsible for complete and accurate study data collection, through patient interactions, survey management, electronic medical records, etc. Perform ophthalmic technical procedures (e.g., visual acuity, tonometry, perimetry, imaging) as required by the study protocol, minimizing the need for outside clinical staff support. Create source documents for accurate data collection. Responsible for the maintenance of subject research charts in adherence to Good Clinical Practice and sponsor requirements. Implement a process to track subject visits and ensure protocol timelines are met. Enter all study and subject data into OnCore clinical trials management system and required sponsor platforms. Work with the Investigators to ensure the timely review and reporting of adverse reactions and severe adverse events. Entering all study subjects visits appropriately to make sure patient billing is accurate. Implement and maintain accurate subject Clincard payments. Lead and manage relationships with sponsors and contractors to conduct site initiation visits, monitoring visits, program audits, etc. Responsible for implementing accurate device and drug accountability processes according to sponsor and regulatory requirements. Specialized Clinical & Diagnostic Research Duties (40% Effort): This position functions as the lead Research Ophthalmic Technician (COT) for all assigned clinical studies, independently performing non-physician patient care, clinical assessments, and advanced diagnostic testing as required by the protocol. This requires advanced knowledge of ophthalmic disease and diagnostic instrumentation. Advanced Diagnostic Imaging & Testing: Independently perform, calibrate, and quality-check a variety of complex ophthalmic diagnostic exams, including but not limited to: Optical Coherence Tomography (OCT), B-scans, corneal topography, microperimetry, full-field stimulus testing (FST), electroretinography (ERG), and specialized visual field testing. Ophthalmic Patient Assessment: Conduct detailed patient workups, including obtaining a thorough medical and ocular history, performing manifest refraction, measuring intraocular pressure (Goldmann or Tonopen), assessing visual acuity, pupillary response, and ocular motility. Clinical Support: Instill eye drops for dilation or other protocol-required purposes and assist the Principal Investigator (PI) with in-clinic minor surgical procedures, injections, or laser treatments. Technical Data Management: Be solely responsible for the generation, quality control, and interpretation of all clinical diagnostic source data used for Case Report Form (CRF) submission and sponsor monitoring. Research Project Management Duties (15%): Responsible for research study start up process to include Preparation of regulatory applications, consent and HIPAA forms and applicable documents to meet institution and sponsor requirements. Liaison between department and the University IRB staff and associated Ancillary Reviews to ensure applicable review are completed (Fairview, Hipco, CTSI, Scientific Review). Work with CTSI Regulatory Services to support Business and Industry protocols to include local and central IRB applications. Develop and manage a tracking system to ensure regulatory review submissions, modification and continuing review deadlines are met. Maintenance of regulatory binders (paper and electronic) and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time. Responsible for implementation of the research protocol in collaboration with the clinical teams to foster an environment of quality research participation within the context of exceptional clinical care. Oversee and responsible for the completion of the study budget process including review of protocol amendments to ensure the budget supports the work required. Work with the department accountant(s) to monitor incoming study payments. Maintain the Oncore system to ensure billing compliance and accurate documentation. Track clinical research projects across the department to include medical students, residents and fellows to ensure projects are tracked and in compliance with the IRB. Coordinate Research Studies with Other Departments (5%): Coordinate research studies for other departments who require ophthalmology services for eligibility. Work with patients to schedule appointments, be present for the exam and or complete the required exams as the COT for the study and CRC for the study, complete all required source documentation for primary Clinical Research Coordinator. Provide support and assistance to the clinical research team. Qualifications All required qualifications must be documented on application materials. Required Qualification: Bachelors' degree and 4 years of clinical or research experience or a combination of related education and work experience to equal 8 years. Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good Clinical Practice guidelines. Computer proficiency and ability to navigate multiple software applications. Detail-oriented with exceptional organizational, planning and problem-solving skills. Ability to work in a complex environment. Ability to work independently, as a part of a team and with changing priorities. Possess excellent communication (written and verbal) and interpersonal skills. Certified Ophthalmic Technician (COT) credential... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U:

Created: 2026-03-07