GDIT is seeking a Clinical Research Coordinator (CRC) in support of the Clinical Investigations Department (CID) at the Naval Medical Center Camp Lejeune (NMCCL). NMCCL conducts operationally relevant clinical research programs directed toward enhancing the performance and survivability of military personnel. The CID currently supports a number of research efforts to include traumatic brain injury, post-traumatic stress disorder, alternative treatment therapies, prevention and treatment of mental health disorders.
Provide research coordinator support for Institutional Review Board (IRB) approved research protocols.
Provide support to CID and Principal Investigator(s) (PI) of each protocol in accordance with written Department of Defense (DoD); Department of the Navy (DoN); Bureau of Medicine and Surgery (BUMED), and NMCCL regulations, policies, and procedures.
Provide consultation; reporting; exchange of information; orientation; teaching; support for the performance of duties and guidance to patients through a research protocol.
Document and maintain records of contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc.
Review new research protocols for consistency, completeness, and compliance with all DoD, DoN, BUMED, NMCCL, and other federal and applicable state regulations and guidelines prior to IRB review.
Assist Research Administration Officer (RAO) with the compilation of and ordering of the required study materials, equipment, and supplies as specified in the research protocol.
Assist with the recruitment, screening and consent of patients utilizing protocol inclusion/exclusion criteria with the subsequent reference of eligible patients to the PI for final evaluation, as dictated by the IRB-approved protocol. Additionally, the contractor shall ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented
Provide education to patients on compliance, possible side effects, drug interactions, and the importance of contacting the coordinator for any possible adverse events.
Coordinate the performance of phlebotomies; electrocardiograms; intravenous infusions; vital signs; specimen collection; MRIs, and other procedures as required by the protocol. Obtain laboratory, neuroimaging, cognitive, vision and hearing results and consult with the PI for follow-up care where indicated.
Process and prepare specimens for lab analysis and shipping.
Assist with the amendment creation, review and reporting of protocol deviations, violations or serious adverse events and Unanticipated Problem Involving Risk to Subjects or Others (UPIRTSO); the submission of continuing review documents and final reports; the preparation of reports and other correspondence regarding specific research protocol(s) for the IRB, granting agencies, industry sponsors and other organizations as required by the regulation and/or protocol.
Perform services in ambulatory care spaces, inpatient wards and outlying clinics with the awareness that such locations present some risk of exposure to infectious diseases(s). In all cases, contractor personnel shall follow all required safety precautions. Some aspects of protocol(s) may be performed on the blast range or in a field environment.
Collect data in a timely, accurate manner and submit the data to coordinating centers as required.
Monitor and make recommendations in regards to necessary actions to maintain regulatory compliance.
Demonstrate competence and possess knowledge of complex regulations; policies and procedures concerning the conduct of clinical trials to include Food & Drug Administration (FDA), Good Clinical Practice (GCP), International council on Harmonisation (ICH) regulations and IND/IDE requirements.
Demonstrate competence and possess knowledge of medical terminology and treatment concepts.
Possess a comprehensive, intensive, practical knowledge of the entire clinical research program to include protocol preparation; processing for approval and continuing review; methods of communication with investigators, command personnel, headquarters personnel and outside agencies; protocol tracking and data storage and consent form regulations.
Assist with the administrative process regarding Personally Identifiable Information (PII), Protected Health Information (PHI) and research protocols.
Demonstrate competency in using desktop and networked computer software, to include intermediate or advanced level competencies with Microsoft Windows and the Microsoft Office suite (Outlook, Word, and Excel). Ability to learn and master proprietary software such as Electronic Institutional Review Board (EIRB) data management software, as these programs are critical to the day-to-day operations of the Institutional Review Board (IRB) and CID.
Assist the CIDH and Directorate of Professional Education (DPE) on a regular basis regarding protocols and related issues to facilitate timely resolution of requests received by the IRB, CIDH, or DPE. Work collaboratively with the IRB Chair, CIDH, DPE, and Research Administration Officer (RAO) to facilitate ongoing development, implementation and maintenance of the human subject's protection program.
Attend seminars, workshops and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations, particularly in an environment of increasingly sophisticated technology.
Participate and/or present at researchrelated education sessions. Assist in the preparation of presentations (poster and oral) at local and national conferences as identified by the PI.
Assist the Research Administration Officer (RAO) to compile the list of required study materials, equipment, and supplies as specified in the research protocol or as required for the performance of their duties. The RAO (Government employee) will place and receive all orders.
Coordinate with PI to ensure all resources are available as necessary to meet research timelines.
Perform research related tasks that require a high level of concentration, extended periods of standing and walking on a regular basis. Must work well under pressure, and be adept at prioritizing and multitasking. Must be comfortable with changing conditions and research workload.
Assist the PI with the administration of complex human research protocols with utilization of proficient managerial, communication and leadership skills. Assist with other research related administrative duties and projects as needed.
Perform other research related and/or administrative tasks as required by the IRB Chair, CIDH, or DPE.
BS or higher in Medicine, Medical Research, Biological Science, Behavioral Health, Health Science, Physiology, or Nursing is required.
Contract requires a minimum of 2 years of experience providing direct coordination or management of research protocols OR one year experience and a certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
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