GDIT is seeking a Clinical Research Coordinator in support of the Naval Medical Center, Portsmouth VA. The position will coordinate and conduct human clinical research in conjunction with the Principal Investigators (PI) of IRB-approved research protocols
Supports the Department Head of Clinical Investigations Department and is accountable for research matters to the PIs of each research protocol in accordance with federal and local regulatory guidelines.
Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA).
For consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc.
Work with the PI to develop and implement recruitment strategies in accordance with IRB/HRPO requirements and approvals.
Recruit and screen research subjects using protocol inclusion/exclusion criteria.
Ensure the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented.
In collaboration with the research pharmacist, ensure correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability.
Ensure subjects receive education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable.
Ensure adequate inventory of study supplies, including drugs, devices, etc.
Prepare other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs
Assist the PI in development of materials and tools necessary to appropriately train individuals involved in the execution of a study related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Train appropriate personnel as needed. Maintain documentation of training.
Coordinate the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol.
Observe universal precautions and OSHA standards when handling specimens.
Obtain laboratory results and consult with the PI for follow-up care as per protocol.
Collect data in a timely and accurate manner and submit information to coordinating centers as required.
Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
Evaluate compliance of research subject and complete documentation of status and progress.
Respond to compliance Officer audit findings and, after consultation with PI, implement approved recommendations.
Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol.
Maintain detailed documentation of the research study including but not limited to subject study charts and databases as required by the protocol, and the Investigator’s File Binder or Regulatory Binder.
Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol. Interact on a regular basis with the PI and study team members regarding the conduct of the research study.
Return telephone calls from research participants in an efficient and timely manner and documents interactions appropriately.
Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons.
Maintain patient confidentiality according to HIPAA and institutional regulations.
Actively participate in CID departmental and command-wide research educational and training programs by providing instruction, presentations, and assistance to research staff as needed.
Assist the compliance Officer with monitoring process to ensure protocol compliance.
Assist principal investigators, research team members, and other staff in the development of, preparation for, and closeout of clinical research studies.
Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols.
What Youll Need:
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.
Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings.
Skills in counseling, guidance, and maintaining interpersonal relationships.
Good typing skills to allow online documentation of patient interactions.
Work requires concentration, periods of standing and walking on a regular basis.
Must work well under pressure, often changing conditions and research workload.
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.
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.