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Job #: R-00019836
Location: San Diego, CA
Category: Life Scientist
Schedule (FT/PT): Full Time
Travel Required: No
Shift: Day
Potential for Telework: No
Clearance Required: Secret
Referral Eligibility: Eligible
Group: Health

Description

Job Requisition:

Institutional Review Board (IRB) Administrator

Job Description:

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.  Successful candidates will demonstrate an ability to 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.

Primary Responsibilities:

1. 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.

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.

Basic Qualifications

a. Masters preferred in the life sciences or psychology

b. A minimum of 6 years of IRB review experience

c. Certification as a Certified IRB Professional (CIP)

d. Experience with the military or consulting in a DoD environment preferred.

e. 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

Desired Qualifications

Previous or current clearance or history of a completed government background check

External Referral Bonus:

Eligible

Potential for Telework:

No

Clearance Level Required:

Secret

Travel:

No

Scheduled Weekly Hours:

40

Shift:

Day

Requisition Category:

Professional

Job Family:

Life Scientist

2000

Health

Leidos

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.

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.

Securing Your Data

Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a Leidos.com email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to spam.leidos@leidos.com.

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.

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