GDIT’s Military Health team is seeking a Clinical Research Coordinator (CRC) to support the Combat Trauma Research Group (CTRG) and Clinical Investigations Department (CID) at the Naval Medical Center Portsmouth (NMCP). The CRC is responsible for providing research coordination support for IRB- and IACUC -approved human and animal research protocols in conjunction with the CTRG investigators.
Work is performed in ambulatory care spaces, inpatient hospital wards, and the animal vivarium. Coordinate research activities of assigned IRB and IACUC-approved study protocols, such as IRB pediatric and adult studies or IACUC animal studies.
Supports the Department Head of CID and is accountable for research related matters to the PIs of each research protocol.
Provide support to the Department Head of CID and the PI of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions.
Ensure all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations.
Work closely with the Senior Research Technician/Supply Purchase officer in identifying the study materials, equipment and/or research animals needed in the research protocol and in accordance with CID IACUC policies and animal facility standard operating procedures.
Coordinate with the PI to ensure all resources, including supplies, are available as necessary to meet research timelines.
Ensure effective communication with patients, their families and/or significant others, providers, clinical staff, clerical staff, and collaborative institutions.
Report data on research studies in accordance with IRB/IACUC-approved protocols and applicable regulations with final government approval.
Assist with recruiting and screening patients using protocol inclusion/exclusion criteria and refer eligible patients to the PI for final evaluation.
Assist Government personnel with ensuring the consent process has taken place effectively and all questions are answered satisfactorily and documented.
Assist with providing education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator.
Assist with coordinating the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol.
Maintain proficiency required to coordinate clinical research such as: communication skills and leadership skills as the coordinator of complex human and animal research protocols.
Maintain proficiency in appointment booking, and coordinating laboratory studies, x-rays, and other tests.
Assist with assigning appropriate randomization number, per protocol design, to subjects.
Assist the Research Pharmacist with ensuring that drugs are correctly dispensed as per protocol.
Assist with maintaining accurate documentation record of drugs received.
Assist with processing and preparing specimens for lab analysis and shipping.
Observe universal precautions and OSHA standards when processing or handling specimens.
Collect laboratory results and consult with the PI for follow-up care.
Ensure collection of data in a timely and accurate manner and submit information to coordinating centers as required, subject to final Government approval.
Ensure reporting of adverse events to the governing agencies (IRB/IACUC) and sponsors as required by protocol and regulations.
Ensure in the research study is in with regulations and standard operating procedures, to include complete documentation of status and progress.
Assist with maintaining detailed documentation of the research study as required by the protocol and the PI’s File Binder/Regulatory Binder.
Assist with preparing reports and other correspondence regarding the research protocol for IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol, subject to final Government approval.
Effectively communicate on a regular basis with the PI, Research Scientist, or staff regarding the conduct of the research study.
Assist with producing protocol amendments and continuing reviews in the eIRB system, subject to final Government approval.
Submit deviation study reports to the IACUC/IRB, subject to final Government approval.
Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency. Contractor personnel shall not function as voting members.
Provides other administrative duties which directly correspond to the aforementioned duties (above).
A Bachelor’s Degree or higher is required.
2+ years of experience coordinating research protocols OR 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).
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.
Working knowledge of U.S. Federal government regulations regarding the conduct of animal research protocols.
Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and research integrity training within one month from start date and additional protocol specific training as required.
Must be a US citizen with the ability to obtain a favorable security investigation
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