Clinical Research Coordinator

About the Job

The Clinical Research Coordinator 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 the 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.

Research Study Coordination (60%)

• 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.

Research Project Management Duties (30%)

• 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 for the Department (5%)

• Coordinate research studies for other departments who require ophthalmology services for eligibility.
• Work with patients to schedule appointments, be present for the exam, complete all required source documentation for primary Clinical Research Coordinator.
• Provide support and assistance to the clinical research team.

Misc. educational and department duties (5%)

• Attend bi-monthly CTSI Clinical…