Assistant Clinical Research Coordinator
Company: General Dynamics Information Technology
Location: San Diego
Posted on: November 22, 2021
Type of Requisition:RegularClearance Level Must Currently
Possess:NoneClearance Level Must Be Able to
Obtain:NoneSuitability:No Suitability RequiredPublic Trust/Other
Required:NACLC (T3)Job Family:ResearchJob Description:GDIT's
Military Health team is looking for an Assistant Clinical Research
Coordinator to support the Naval Health Research Center (NHRC)
activities in San Diego.This position will provide support services
for operational infectious disease surveillance, accredited
clinical laboratory testing, diagnostic evaluations, clinical
research support and scientific research services. As the Navy hub
for the Armed Forces Health Surveillance Center, the NHRC
Operational Infectious Diseases Directorate conducts on-going,
laboratory-based surveillance of US military populations in unique
environments to quantify and study the etiology of infectious
illnesses.In this role, a typical day will include:
- Provide operational support for diagnostic evaluations,
clinical studies, and/or clinical trials supported by NHRC and
sponsored by Federal Agencies or private companies.
- Maintain Good Clinical Laboratory Practices standards in
performance of laboratory testing.
- Maintain the existing Government approved QA/QC (quality
assurance/quality control) program that meets accreditation
standards (such as CAP- College of American Pathologists) and
improves the safety and quality of the laboratory.
- In cases of national emergency or infectious disease outbreaks,
the COR will notify the contractor. The COR will also notify the
Contracting Officer. The contractor shall provide rapid assessment
as they occur and provide appropriate personnel and response task
forces with information that can be used to develop effective short
and long-term solutions.
- Provide support for protocol driven scientific research
addressing infectious diseases
- Shall be eligible for enrollment in a Biological Personnel
Reliability Program (BPRP)
- Recruit and screen subjects using protocol inclusion/exclusion
- Assign appropriate subject identification number per protocol
- Ensure that the consent process has taken place effectively and
all questions are answered satisfactorily and documented.
- Input research data into database.
- Report adverse events to the IRB-protocol PI for submission to
governing agencies and sponsors as required by protocol and
- Evaluate compliance of research subject to protocols and
complete documentation of status and progress.
- Conduct telephone or face-to-face interviews and mail
government approved information for follow-up visits.
- Maintain detailed documentation of the research study including
but not limited to individual patient files, databases as required
by the protocol and the Investigator's File Binder/Regulatory
- In collaboration with OID, PIs, and assigned medical monitor,
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
- In collaboration with key research personnel and investigators,
process and prepare specimens for lab analysis and shipping.
- Interact on a regular basis with the PI regarding the conduct
of the research study.
- Attend conferences (approved by the COR) and other meetings as
required by the protocol, the PI, or the sponsoring agency.
- Respond to research participants in an efficient and timely
manner and documents interactions appropriately.
- Observe safety regulations when working in ambulatory care
spaces and inpatient wards (such as the use of government provided
personal protective equipment (PPE)).
- Provide other research support duties that are within the scope
of work.WHAT YOU LL NEED:Required:
- BS , MS or MPH preferred
- 1+ years experience within research (clinical)
- Working knowledge of U.S. Federal government regulations
regarding the conduct of human clinical research.
- Proficient in scheduling and communicating with
- Proficient in writing and editing to assist PIs in preparation
of their manuscripts, scientific abstracts, and/or research
- US Citizenship required and ability to obtain public
- Current 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).
- Complete human protection training developed by the
Collaborative Institutional Training Initiative (CITI) within one
month from the start of performance.
- Must be proficient in medical record reviews and searches. In
order to accomplish this task, the contractor personnel must have
experience in the use of clinical computer systems such as
CliniComp (Essentris), Cerner (MHS-Genesis) or SPSS.
- Work requires concentration, periods of standing and walking on
a regular basis; must work well under pressure, in often changing
conditions and research workload.
- Ability to exercise independent judgment to determine
appropriate action and priorities in the performance of duties
outlined herein.WHAT GDIT CAN OFFER YOU:
- 401K with company match
- Customizable health benefits packages
- Internal mobility team dedicated to helping you own your
- Challenging work that makes a real impact on the world around
- Full-flex work
Scheduled Weekly Hours:40Travel Required:NoneTelecommuting
Options:Telecommuting Not AllowedWork Location:USA CA San
DiegoAdditional Work Locations:This position requires being fully
vaccinated against COVID-19 by January 18, 2022 or the start date,
if after January 18. Individuals who work in or reside in Texas or
Montana or work outside of the United States may be excluded from
this requirement. 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. Associated topics: clinical, clinical development,
clinical informatics, clinical trial, coordinator, lab, laboratory,
research, research coordinator
Keywords: General Dynamics Information Technology, San Diego , Assistant Clinical Research Coordinator, Other , San Diego, California
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