GDIT 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. Tasks include:
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 (note - does not include actual performance of these clinical procedures). Maintain proficiency in appointment booking, and coordinating laboratory studies, and other tests.
Assist with assigning appropriate randomization number, per protocol design, to subjects.
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.
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.
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.
May attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.
Bachelors degree in a scientific or related field or (6 years of relevant experience may be substituted for a degree)
Minimum of 2 years of clinical research coordination experience
Must be a US citizen with the ability to obtain a favorable NACLC T3 security investigation
Previous research animal handling experience preferred
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.