Job ID 12390 Location Case Main Campus Full/Part Time Full-Time Regular/Temporary Regular Job Description POSITION OBJECTIVE Working under limited supervision and closely with the principal investigator(s), provide organizational support for operations of National Eye Institute, foundation, and other funded trials in the Vision Research Coordinating Center (VRCC) within the Department of Ophthalmology and Visual Sciences. One of the primary studies is the ongoing Diabetes Endothelial Keratoplasty Study (DEKS, principal investigator Lass) which is studying if corneal clarity and endothelial cell loss 1 year following endothelial keratoplasty is superior for donor corneas without diabetes than for those with diabetes. 1420 patients will be enrolled across 28 sites with donors coming from 13 eye banks around the country. Responsibilities will also include the recruitment and retention of subjects locally in ophthalmology trials including the NIH funded COAST Study (Clarifying the Optimal Application of SLT Therapy) and/or other trials performed by investigators within the department. Responsibilities will also include other research coordinator functions locally or across sites when functioning as part of a Coordinating Center for multi-center studies, protocol compliance, regulatory documentation, Institutional Review Board (IRB) submissions, management of participant reimbursement, study budget and coverage analyses, human subject protection, and the promotion and growth of the center. ESENTIAL FUNCTIONS Work closely with the principal investigator or Vision Research Coordinating Center director on the various clinical research projects in the center including the DEKS. Coordinate start-up activities including coordination of study initiation meeting with sponsor, IRB submissions, and informed consent documents following required templates. (15%) Evaluate and recruit study participants through internal chart reviews and physician referral, screen subjects for eligibility by evaluating protocol inclusion/exclusion criteria, interview potential participants, and obtain subject's informed consent according to Office of Human Subject Protection guidelines discussing the risks, benefits, and alternatives of participating in research. (10%) Implement study procedures and track mechanisms to ensure participant evaluations occur at appropriate intervals and promote subject compliance by providing support and education following the goals and plans established by sponsors, investigators and research manager including managing participant compensation as specified in the Protocol. (15%) Manage study protocols, which include coordination of required study procedures (coordinate ophthalmic examinations, history and physical examinations, laboratory requirements, etc.), use of the institution's investigational pharmacy, shipment and storage of study medications and supplies, organize certified technicians and photographers, and coordination of investigator schedules. (13%) Gather reports and submit the following as needed to the governing IRB(s) for each ongoing study: protocol amendments, safety reports, deviations, and continuing renewals. (10%) Complete study charts and source documentation and case report completion for each study participant to meet the standards and requirements of the sponsor, IRB office, and FDA with 100 percent accuracy. (10%) Maintain certifications, master trial file and regulatory binders, data query and resolution in a timely manner and participate in internal and/or external audits with study sponsors, clinical research organizations, and clinical research associates (study monitors), as required for each study. (10%) NONESSENTIAL FUNCTIONS Execute minimal clinical research protocol activities (within their experience and as certifications allow) such as simple visual acuity assessment, management of study medic