Assists with providing organization and support to the research functions of Graduate Medical Education and other hospital departments as needed. Participates in complex clinical trial duties with assistance as needed.
Assists with providing organization and support to the research functions of Graduate Medical Education and other hospital departments as needed. Participates in complex clinical trial duties with assistance as needed. Has knowledge of the clinical trial process and the regulations governing it. Performs data management and assists with interpretation specific to clinical trials through appropriate Carilion-affiliated research groups and institutions. These activities include Institutional Review Board (IRB) approvals, registration, compilation, and submission of data and the monitoring of quality of care and study compliance. Maintains a system for perpetuation of effective data flow.Assists with coordinating various disciplines and functional areas as they relate to each specific trial. Collects, submits and maintains appropriate patient data and regulatory documents. Communicates data to appropriate resources in an effective and efficient manner.Utilizes knowledge and attention to detail to execute all data management activities. Maintains a system for organizing, planning and coordinating the work flow related to IRB approval and patient accruals to clinical trials, including development of appropriate consent forms, patient and family education and communication regarding adverse drug reactions. Serves as a patient resource, creating patient teaching plans and educating patients and family members.Assists in maintaining a quality control program as mandated by the study groups and Carilion Clinic. Assists with the evaluation of the quality of patient care and compliance to protocol requirements. Uses problem solving skills to identify opportunities for improvement and completes projects in a timely and effective manner. Uses exceptional communication skills as a liaison between institutional investigators, IRB, the affiliated study groups? Office of Sponsored Programs and study sponsors. Coordinates and assists with the maintenance of investigational drug records.Maintains a system of effective communications among physicians and staff regarding the availability of clinical trials for patient accrual and eligibility requirements. Responsible to work with principal investigator to achieve a target number of accruals.MINIMUM QUALIFICATIONS:Education: Bachelor´s degree in biology or medical/clinical sciences (i.e. physiology, nursing, etc.), or a related field. Graduation from an accredited nursing program required.Experience: One year of Clinical Research experience preferred.Licensure, Certification or Registration: License or certification specific to the discipline according to Virginia requirements. Current license to practice as a Registered Nurse.Other: Thorough knowledge of medical terminology and human anatomy and physiology. Working knowledge of the disease/condition under study, the clinical trial process and good clinical practices. Proficient in the application of federal regulations and the Good Clinical Practices governing clinical research. Must be competent in word processing and spreadsheets. Proficient with data base management systems and statistical software, research methodology, and statistical analysis. Must have effective interpersonal and problem-solving skills. Must be self-directed and excel in attention to detail. Must use good judgment with regard to priorities and deadlines.Service Excellence and Quality are hallmarks of Carilion Clinic. As a team member, you will be expected to consistently deliver the best in care and customer service. As an employee, you will demonstrate respect, dignity, kindness and empathy in each encounter with our patients, families, visitors and with each other.Carilion Clinic is an Equal Employment Opportunity/Affirmative Action Employer.