The Biobehavioral Research Division within the Military and Veterans Health Services Operation at Leidos has a need for an Institutional Review Board (IRB) Administrator.
The individual selected for this position will perform a variety of duties to support the Institutional Review Board at the Naval Health Research Center, San Diego, CA. Specifically, work efforts may include reviewing documents, drafting communications, maintaining records and documents and assisting with audits.
Support the Naval Health Research Center IRB functions and HIPAA Privacy Office functions by reviewing all NHRC studies for compliance with DoD, Navy, and federal regulations and communicate needed changes to study teams for Exempt, Expedited, Full-Board (Initial, Continuing, and Modification) reviews including projects that are FDA-regulated.
Draft formal approval letters, information-needed memos, emails, and other written communication according to site-specific, Navy, and DoD, and DHHS guidelines.
Maintain IRB records and IRB meeting minutes to document compliance with relevant human subject protection regulations.
Maintain document archives in electronic and paper format according to DoD regulations.
Maintain training files and assist personnel with training requirements and technical assistance.
Create and maintain tracking system for Not Human Subject Research determinations and Data Use Agreements.
Assist with site audits as needed, in particular with HIPAA compliance.
Demonstrate knowledge and understanding of the federal regulations on human research protection
Bachelor’s Degree required, Master’s Degree preferred, in the sciences preferred
A minimum of 6 years’ of IRB review experience; previous experience with Institutional Review Board (IRB) communications, to include coordination of IRB submissions
A minimum of 2 years’ experience in research administration or project management in an academic or research environment
Certification as a Certified IRB Professional (CIP), held for at least one year.
Experience with the military or consulting in a DoD environment preferred.
Experience in managing research compliance (HIPAA, Privacy) with investigators and other research staff preferred
Strong skills to communicate effectively both orally and in writing; be able to communicate with a highly diverse group of people; possess effective organizational and analytical skills; must be highly organized and pay strong attention to detail and accuracy
Ability to work independently and as a team member, in fact-paced, demanding, research environment in an effective and flexible manner
Proficient with Windows based computer systems including MS Office
Previous or current clearance or history of a completed government background check
Naval Health West - NHW
In order to enter Leidos facilities in the U.S. and to attend Leidos events outside our facilities, employees are required to be vaccinated for COVID-19 or maintain proof of a negative COVID-19 test within 96 hours of entry. In addition, we are receiving guidance from certain customers that onsite contractor personnel will need to be fully vaccinated to access customer facilities. If you are not vaccinated, please consider getting your COVID-19 vaccination as soon as possible. If you have any questions, please contact your Talent Acquisition POC.
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, civil, and health markets. The company’s 43,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $12.30 billion for the fiscal year ended January 1, 2021. For more information, visit www.Leidos.com.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here.
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Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.