General Dynamics Information Technology Clinical Research Coordinator in Portsmouth, Virginia
General Dynamics Health Solutions is seeking experienced Clinical Research Coordinators in support of the Naval Medical Center Portsmouth. These positions provide research coordinator support for Institutional Review Board (IRB)-approved clinical research supporting the Obstetric Simulation Training and Teamwork (OB-STaT) to Reduce Postpartum Hemorrhage protocol, with the goal to decrease post-partum hemorrhage rates, improve hemorrhage management, and improve patient satisfaction when post-partum hemorrhage occurs. These positions will coordinate and conduct human clinical research in conjunction with the Principal Investigators (PI) of the IRB-approved research protocol in Healthcare Simulation Department. Responsibilities to include:
Coordinate the research activities of assigned IRB-approved study protocols. Specific protocols that require the CRC’s support will be determined by the Department Head of CID in consultation with the CRC. Protocols will include adult subjects.
Support the Department Head of CID, accountable for research matters to the PIs of each research protocol.
Support the Department Head of CID and the Principal Investigators of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with medical requirements and professional standards in terms of quality and appropriateness.
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 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 study databases when not traveling to study sites.
Report adverse events to governing agencies and sponsors as required by protocol and regulations.
Evaluate compliance of research subject and complete documentation of status and progress.
Conduct telephone, face-to-face interviews or mail 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 and PIs, 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 regarding the conduct of the research study.
Upon advanced written approval by the COR, attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.
Return telephone calls from 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).
Travel to each of the seven regional Naval Military Treatement Facility study sites for up to 14 days to collect clinical data; to consent, distribute and administer patient and team member/staff surveys; and to directly observe team performance.
Bachelors Degree in a scientific discipline.
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).
2-5 years of related experience.
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 start date.
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) and Cerner (MHS-Genesis)
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.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.
Requisition ID 2018-39372
of Openings 2
Job Location USA-VA-Portsmouth
Job Function Science and Engineering
Security Clearance Level None
Full/Part Time Full Time