GDIT is seeking a Clinical Research Coordinator Assistant in support of the Naval Health Research Center (NHRC) Operational Infectious Disease (OID) Field Surveillance and Laboratory 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. This position will provide support services for operational infectious disease surveillance, accredited clinical laboratory testing, diagnostic evaluations, clinical research support and scientific research services.
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 criteria.
Assign appropriate subject identification number per protocol design.
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 regulations.
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 Investigators File Binder/Regulatory Binder.
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 protocol.
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.
QUALIFICATIONS Required Skills and Experience:
BS degree required.
2+ years experience in a clinical research setting, preferably as a Clinical Coordinator
US Citizenship required and ability to obtain public trust
Desired Skills and Experience:
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).
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.
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.
Proficient in scheduling and communicating with participants.
Proficient in writing and editing to assist PIs in preparation of their manuscripts, scientific abstracts, and/or research presentations.
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.
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.