GDIT supports the Naval Medical Center San Diego (NMCSD) C5 Gait Analysis Laboratory. The over-arching goal is of the position is to assist each MTF in the strengthening of evidence-based orthopedic rehabilitation care that results in optimal functional outcomes of combat and combat-related musculoskeletal injuries. The Research Coordinator supports research studies at The Naval Medical Center San Diego in San Diego, California. Serves under the direction of the GDIT Program Manager.
• Performs a broad range of administrative duties in support of ensuring the research program remains in compliance with the Federal Common Rule regulations to protect human research subjects. • Responsible for managing preparation, submission, and maintenance of research protocols submitted by researchers and coordinating actions throughout the approval process. • Facilitates the preparation, submission, and tracking of IRB documentation. • Following protocol approval, research protocol record maintenance and data management are primary responsibilities of the position. • Requests, compiles, and analyzes data to develop special and periodic reports required by the facility Research Director, MTF, CIRO, or external agencies, as requested. • Protects human subjects by being aware of ethical, legal and procedural requirements for protocol development. • Entry of all onsite study information and data into the PDMS; learns to model protocols into PDMS. • Maintain knowledge of all compliance issues, such as human subject protections and responsible conduct of research. • Assist with coordination with members of other federal agencies, e.g. the Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP) in Health and Human Services, the Clinical Investigation Regulatory Office (CIRO), Medical Command (MEDCOM) and the Regulatory Compliance and Quality office of the Medical Research and Materiel Command. (MRMC). • Coordination with state and private universities and private research organizations/ institutes is also a function.
QUALIFICATIONS: • Bachelors degree required in science or healthcare-related field • At least 3 years experience in clinical research setting required • Interpersonal skills to work effectively with patients and staff • Familiarity and experience with research design, data collection and computerized systems, and experience with laboratory management and administrative activities highly preferred • Ability to learn new software quickly, troubleshoot computer related issues, and provide a high attention to detail Preferred: • Experience in or exposure to research in a hospital setting is preferred. • Experience clinical administration and/or clinical documentation preferred • Experience with clinical trials preferred • CITI certification is strongly preferred. • Experience with IRB administration and data management is preferred
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GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.