Clinical Research Coordinator
Company: General Dynamics Information Technology
Location: Camp Lejeune
Posted on: May 15, 2022
Job Description:
Travel Required: NonePublic Trust: NACLC (T3)Requisition Type:
RegularGDIT's Military Health Team is seeking a Clinical Research
Coordinator to support the Naval Medical Center Camp Lejeune
(NMCCL) Clinical Investigations Department
(CID).Responsibilities:
- 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.Qualifications:
- 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.WHAT GDIT
CAN OFFER YOU:
- Challenging work that makes a real impact on the world around
you
- Internal mobility team dedicated to helping you own your
career
- 401K with company match
- Diverse, highly collaborative teams
- Professional development, education assistance, certification
and training opportunities#GDITPRIORITY#GDITFedHealthJobs
#MILITARYHEALTH
#MILITARYHEALTHGDITJOBS#GDITClinicalResearchJobs#GDITResearchJobs
About Our WorkWe 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.COVID-19 VaccinationGDIT does
not have a vaccination mandate applicable to all employees. To
protect the health and safety of its employees and to comply with
customer requirements, however, GDIT may require employees in
certain positions to be fully vaccinated against COVID-19.
Vaccination requirements will depend on the status of the federal
contractor mandate and customer site requirements.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.
Keywords: General Dynamics Information Technology, Jacksonville , Clinical Research Coordinator, Healthcare , Camp Lejeune, North Carolina
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