The Clinical Research Coordinator provides complete management of the clinical trials for the Department of Obstetrics and Gynecology, including research in the areas of Maternal Fetal Medicine, Obstetrics, Gynecology, and Urogynecology.  The coordinator acts as liaison between the academic community, local community, multiple government agencies and/or commercial sponsors and the Department to facilitate all clinical and practical aspects of the clinical trial.  The coordinator, working independently, interacts with members of the unit to promote the goals of research, education, and patient care as defined in the mission statement of the Department.  Along with the investigator, the Clinical Research Coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the Clinical Research Coordinator is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory file.  The coordinator is available to answer questions or evaluate symptoms and/or problems of patients in trials using sound clinical judgment to suggest additional referrals or appropriate follow-up.  Weekend and holiday call rotation may be necessary to perform clinical procedures, if required by specific protocols.  The coordinator manages multiple complex projects simultaneously with overlapping critical time frames, assigning priorities and delegating work appropriately.

Possesses a full understanding of the clinical research process, study designs and regulatory standards of Good Clinical Practice and adheres to standards for scientific integrity mandating honest and truthful behavior in collecting and interpreting data for patients and sponsors

Supervises clinical research related activities including registration, maintenance and submission of patient data; pathology and laboratories results; drug dispensing; patient compliance; study results; adverse events; and follow up

Independently conducts, analyzes and evaluates all clinical research activities and makes recommendations to principal investigators or designated persons for any required changes

Maintains historical references by facilitating entry, editing, reviewing, management, reporting, and documentation of clinical trials data

Orders investigational drugs and/or devices as needed for protocol purposes and maintains inventories of drugs and devices to ensure that federal guidelines are met

Develops consent forms consistent with Food and Drug Administration (FDA), Institutional Review Board (IRB), and sponsor requirements

Maintains data from clinical studies in order to prepare interim, annual, and close out reports, and to provide statistical information on all clinical research protocols as required by the IRB, sponsor, and department

Maintains responsibility for updating Protocol, Regulatory Binders with addenda, amendments, closure notices, severe adverse drug reaction reports, and other FDA regulated documentation

Evaluates potential volunteers on an individual basis and obtains in depth medical history as related to study inclusion/exclusion criteria

Meets personally with patient volunteers to explain study requirements, and obtains informed consent prior to study screening

Organizes exam rooms in preparation for participants’ exams and procedures, determining equipment and other supplies

Assist with physical exams, endometrial and cervical biopsy, ultrasound, pap smears, colposcopy, catheterization, contraceptive rod insertion and removal, cervical mucus checks, post coital exams, and other procedures as required by protocols

Dispenses medication and educates patients on the correct method of administration of study drug and/or device, and documentation of pertinent medical information required

Provides health education to patient volunteers and encourages interventions for healthy living

Identifies potential disease processes and brings to physicians’ attention for evaluation, diagnosis and treatment

Provides counseling to patients in regards to laboratory results, side effects, etc., and suggests required follow up

Orchestrates protocol specific patient assessment throughout duration of study and any additional visits necessary to evaluate the health and safety of participants

Attends off site patient care visits at other laboratories, pharmacies, doctors’ offices, and hospital departments, to assess and evaluate participants according to protocol requirements

Oversees patients’ adherence to study requirements and makes necessary adjustments to ensure compliance with protocol (medication administration, diary card completion, concomitant medications, and adverse events)

Maintains proficiency in phlebotomy skills, intramuscular injections, ECG, and other clinical skills

Bachelor’s degree in nursing.  Prior nursing experience in research projects.  Must be licensed RN in Virginia. Ambulatory care and Clinical experience in family medicine desired. Customer service-oriented individual is required.