GDIT is seeking a Clinical Research Coordinator in support of the Clinical Investigation Department (CID) at the Naval Medical Center Camp Lejeune (NMCCL). CRCs support the Department Head of the CID and coordinate and conduct human clinical research in conjunction with the Principal Investigators (PI) of IRB-approved research protocols at NMCCL.
Coordinate the research activities of IRB-approved study protocols. Protocols will include both pediatric and adult patients, animals and human anatomical specimens (including cadavers). The specific protocol(s) requiring CRC support shall be determined by the Department Head of CID.
Support and conduct research in conjunction with the PIs of the assigned IRB-approved protocols.
Support to the Department Head of CID and the PIs of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, and Bureau of Medicine & Surgery (BUMED) instructions
Recruit and screen subjects using protocol inclusion/exclusion criteria.
Administer and collect questionnaires from patients and healthcare providers at study sites.
Observe patient care teams and complete teamwork questionnaires at local study sites.
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 Investigator's File Binder/Regulatory Binder.
In collaboration with CID, 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 local 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.
BS preferred, or lieu of a degree an additional 6 years of CRC experience.
2+ years experience as a CRC with experience recruiting and consenting patients, preparing documents such as continuing reviews for IRB submission, and experience using data collection tools (DCTs).
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.
Must be a US citizen with the ability to obtain a favorable NACLC T3 security investigation.
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).
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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.