GDITs Military Health Team is seeking a Clinical Research Coordinator to support the Naval Medical Center Camp Lejeune (NMCCL) Clinical Investigations Department (CID).
Provide research coordinator support for Institutional Review Board (IRB) Government approved research protocols.
Provide support to CID and Primary Investigator(s) (PI) of each protocol in accordance with written Department of Defense (DoD); Defense Health Agency (DHA); Research Regulatory Oversight Office (R2O2), Bureau of Medicine and Surgery (BUMED), and NMCCL regulations, policies, and procedures.
Assist and consent subjects. Communicate with research subjects; via telephone or in person and ask relevant research questions as per protocol. Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented. Arrange for research subject follow-up. 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 Government provided new research protocols for consistency, completeness, and compliance with all DoD, DHA, R2O2 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 subject to final Government approval of the required study materials, equipment, and supplies as specified in the research protocol, performed under this task order.
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 in accordance with Government approved protocols.
Coordinate the performance of phlebotomies; electrocardiograms; intravenous infusions; vital signs; specimen collection; MRIs, and other procedures as required by the Government approved protocols. 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.
Collect data in a timely, accurate manner and submit the data to coordinating centers as required.
Have the ability to speak fluent English and to communicate in a professional, concise and effective manner with peers, colleagues and customers, both orally and written.
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.
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, 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.
Participate and/or present at research‐related 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.
Assist the Principal Investigator (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 data collection as per Government protocol and transfer data sheets into Microsoft Excel and Statistical Package for the Social Sciences (SPSS) databases (if applicable). Prepare progress reports.
Obtain laboratory, neuroimaging, cognitive, vision and hearing results, and other applicable patient medical records/reports as required by Government protocol. Consult with the PI for follow up care where indicated.
BS or higher in medicine, medical research, biological science, behavioral health, health science, physiology or nursing PLUS minimum of two years’ experience as a CRC 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
Will consider AA and 6 years of experience as a CRC providing direct coordination or management of research protocols
CCRC certification a plus
Must be a US Citizen with the ability to obtain a favorable Public Trust security investigation prior to start date.
This position requires being fully vaccinated against COVID-19 by December 8, 2021 or the start date, if after December 8.
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
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.