The Office of Clinical Research Operations (OCRO) is a core facility that supports the overarching Geisinger mission to enhance quality of life through an integrated health service organization based on a balanced program of patient care, education, research and community service. The OCRO aims to provide easy access and use of clinical research operations support within Geisinger for clinician investigators in the conduct and management of clinical trials with patient-care components. The OCRO provides a primary point of contact for sponsors and investigators interested in conducting clinical research at Geisinger and assists investigators with study feasibility analysis and selection, staffing per study needs, recruitment, budget and financial management.

As a result of Geisinger's investment in the electronic health record (EHR) and our stable population, the OCRO has been able to pioneer the strategic use of the EHR for identifying and enrolling a large number of patients into large randomized clinical trials. OCRO has successfully implemented these strategies in several multi-site industry-sponsored trials in a variety of therapeutic areas to out-enroll most other sites, and sometimes other nations.

At this time, services can be accessed at three regional hospital campuses (Geisinger Medical Center, Geisinger Wyoming Valley and Geisinger Community Medical Center) and several outpatient clinics. We service clinical department areas such as, but not limited to, cardiology, vascular surgery, thoracic medicine, endocrinology, general internal medicine, laboratory medicine, obstetrics and gynecology.

Research coordination and patient care services are offered for all types of sponsored studies including internally- and externally-funded (e.g., industry, National Institutes of Health, foundation).

Services

Research coordination services:

• Provide Good Clinical Practice-trained nurse coordinators (Association for Clinical Research Professionals) and clinical research assistants.
• Conduct study feasibility/population assessment/project planning.
• Develop study recruitment/retention strategies.
• Manage study start up, ongoing conduct and close out.
• Include IRB application, regulatory document management, recruitment tracking, financial management, research staff training and communications and study quality assurance reviews.

Participant care services:

• Provide research nurses and clinical research assistants.
• Include research-only care such as informed consent process, specimen collections, data collection, medication/treatment administration, participant education and questionnaire administration.