The Biobehavioral Research Division within the Military and Veterans Health Services Operation at Leidos has a need for an Institutional Review Board Support Specialist.
The individual selected for this position will perform a variety of research support duties for the Institutional Review Board (IRB) at the Naval Health Research Center, San Diego, CA. Specifically, work efforts may assisting the IRB Administrator and government IRB chair to include reviewing documents, drafting communications, maintaining records and documents and assisting with audits. Successful candidates will scientifically evaluate science research protocols across a multitude of health domains and make a recommendation as to the soundness of the research methods, study subject selection, ethical treatment of subjects, potential health and privacy risk in the context of existing FDA, HIPAA, CITI and other governing Federal policy with regard to human and animal research. Combined experience in the life sciences and human and animal subject research, policy and regulation is required.
1. Support the Naval Health Research Center IRB Administrator, IRB functions and HIPAA Privacy Office functions.
2. Draft formal approval letters, information-needed memos, emails, and other written communication according to site-specific, Navy, and DoD, and DHHS guidelines.
3. Maintain IRB records and IRB meeting minutes to document compliance with relevant human subject protection regulations.
4. Maintain document archives in electronic and paper format according to DoD regulations.
5. Maintain training files and assist personnel with training requirements and technical assistance.
6. Create and maintain tracking system for Not Human Subject Research determinations and Data Use Agreements.
7. Assist with site audits as needed, in particular with HIPAA compliance.
- BS/BA in the life sciences or psychology
- A minimum of 3 years of IRB staff experience
- Experience with the military or consulting in a DoD environment preferred.
- Have sound knowledge of medical terminology, clinical terminology, clinical research management, and IRB submission/filing guidelines
- Strong skills to communicate effectively both orally and in writing; possess effective organizational and analytical skills; proficient with Windows based computer systems including MS Office
Certification as a Certified IRB Professional (CIP)
Previous or current clearance or history of a completed government background check
External Referral Bonus:Ineligible
Potential for Telework:No
Clearance Level Required:Secret
Scheduled Weekly Hours:40
Job Family:Life Scientist
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.
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