Clinical Research Associate - IRB Administrator

Clearance Level
None
Category
Research
Location
San Diego, California

REQ#: RQ108658

Travel Required: None
Public Trust: NACLC (T3)
Requisition Type: Regular
GDIT is seeking Clinical Research Associate / IRB Administrator to support the Naval Medical Center in San Diego, CA (NMCSD). The mission of the NMCSD is to prepare to deploy in support of operational forces, to deliver quality health services, and to shape the future of military through education, training, and research. In order to optimize the performance in support of accomplishing its mission, the NMCSD’s Clinical Investigations Department (CID) requires the services of a Clinical Research Associate – Administrator to support research investigators, other research assistants and/or nurse researchers in the performance of moderately complex research and experimentation.This role will provide direct support to the Institutional Review Board (IRB) office.
  • Ensures protocol plans, timelines and revisions of protocols are updated and submitted on time.
  • Recruit, educate, and obtain study subject enrollment and consent.
  • Administer questionnaires, collect, and analyze data according to research protocols and report results.
  • Complete case report forms, maintain up-to-date research logs, schedule appointments, prepare recruitment patient letters, and various other study correspondence as required.
  • Manage data according to prescribed standards and transcribe data in case report or data forms.
  • Prepare documents for statistical analysis and descriptive data.
  • Follow-up with study subjects in accordance with research protocol(s).
  • Collaborate with other members of the research team to ensure consistent practice in patient care management.
  • Ensure compliance with subject consenting and reporting of adverse events and side effects.
  • Adhere to legal, professional, and ethical codes of conduct with respect to confidentiality and privacy.
  • Ensure that all research efforts are in compliance with Federal, agency, and IRB-specific requirements and regulations.
  • Schedule and maintain calendar of data collections, appointments, and updates.
Qualifications:
  • Bachelor’s Degree in a scientific discipline.
  • 2 years of related experience in scientific research and analysis.
  • Experience managing the Institutional Review Board (IRB) process including interactions.
  • Experience with eIRB a plus.
  • Knowledge of the Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI).
  • Experience with Windows-based computer systems and applications to include Microsoft Word, Excel, and Outlook email.
  • Must maintain good communication skills with patients and other health care personnel.
  • Possess experience with physiological data collection software.
  • 2 years specific training and/or experience completed or performed in Human Subjects Research preferred.
  • Must be a US Citizen with the ability to obtain a favorable Public Trust security investigation prior to start date.
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COVID-19 Vaccination Requirement: To protect the health and safety of its employees and to comply with customer requirements, 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.

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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.