It is the mission of East Carolina University (ECU) Brody School of Medicine (BSOM) and ECU Health to provide exemplary medical education/training for physicians at the undergraduate and graduate levels. Additionally, it is the mission of BSOM to provide model comprehensive primary and consultative subspecialty care to patients in eastern North Carolina, to advance scientific knowledge through basic, translational, and clinical research, and to provide continuing medical education opportunities for physicians in the region. The Office of Clinical Research (OCR) will be a newly established central office in BSOM designed to support the management and conduct of clinical research while promoting compliance. This is accomplished through standardizing the approach to clinical research across the various research centers and departments in BSOM and ECU Health and supporting investigative teams through regulatory and operational assistance, and enhancements in study management and oversight.

Assist with Research Preparation, Enrollment, Data Collection & Reporting, including but not limited to 50%: Coordination: work independently and with the research team on all study requirements to ensure the study is conducted according to the protocol, federal regulations, and institutional guidelines. Additionally, this position will develop materials, execute procedures, and monitor research activities in conjunction with the sponsor/research team. Regulatory: assist with regulatory and study documentation, such as preparing Institutional Review Board applications, consent forms, patient binders, annual reports, and training guides and SOPs. Prepare all protocol-required materials in order to successfully complete the study. This position will also be responsible for assisting with monitoring visits and audits. Recruitment: screen patients for eligibility, consent / enroll subjects into studies, and monitor enrollment goals. Data Management: collect data from patients and medical records, recording study data as prescribed by study protocol, exhibiting the highest ethics with regard to data collection, maintaining patient enrollment logs and files, analysis of data to determine eligibility of patients to enroll and participate in the study, use of online programs to record data, host site visits by study sponsor. Complete Adverse Event Reports as required by the study protocol. Work with the research investigators to resolve queries as needed. Patient education, including informed consent, education about study participation and the expectations of participants (federal regulations, safety precautions), education about study protocol including risks involved, telephone follow-up with patients, following OSHA and HIPAA guidelines in all situations, providing communicative access to study families for questions pertaining to the study. Other operational tasks as required. Clinical/Patient Care 25%: Ensure procedures required by study protocol, such as laboratory tests, EKGs, echoes, x-rays, bone density, etc. are performed and documented correctly. Guarantee that study related procedures are performed within timelines outlined in the protocol or study plan. Collect, process, and ship biospecimens. Other clinical duties as required. Communication and Oversight 15%: Maintains documentation of enrollments, tracks metrics, and outcomes, and produces related reports as requested. Consults and collaborates with clinical research leadership to ensure studies remain on track for target enrollment and closure. Demonstrates a customer-focused style of communication, problem-solving, and collaboration Coordinates with internal functional departments to ensure various research activities are aligned with protocol, clinical flows, and those mutually agreed-upon timelines are met. Conducts process improvement through evaluation of workflows, development of documentation, and communication with key stakeholders. Direct and frequent communication with principal investigators and other clinical staff Must work as a part of a team. It is essential that this individual establish and consistently maintain a positive relationship with study participants, investigators, clinicians, coworkers, and related personnel. This individual may act as a liaison between institutional investigators, industry sponsors, reference laboratories, federal supervising agencies (NIH and FDA), and institutional personnel. This position will require direct communication with collaborating researchers, technicians, data coordinators, clinical and clerical personnel within the University and health system. This position also involves direct communication with patients (and potentially legal guardians) to see that they understand the purpose of the study and its risks and benefits. Attends team meetings, prepares reports, and communicates additional information around study activities as needed. Financial 10%: Assist with financial reconciliation, invoicing, and budgeting including but not limited to Medicare coverage analysis, clinical trials participants list, and billing compliance. Communicate regularly with research financial analysts when research procedures are conducted.

Bachelors degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

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