Due to the COVID-19 pandemic, employees are highly encouraged to work remotely from their home office, although weekly visits to the Naval Health Research Center in San Diego will be required.
Leidos is currently seeking a full-time Regulatory Affairs Specialist to support the Deployment Health Research Program at the Naval Health Research Center (NHRC) in San Diego, CA. The Regulatory Affairs Specialist will be responsible for the coordination, preparation, and submission of regulatory documents for multiple new and ongoing research programs within the department. The selected candidate will provide expertise, guidance, and direction will work closely with the studies’ leadership and stakeholders, including Principal Investigators, funding sponsors, military personnel, subject matter experts, consultants, analysts, and research support personnel as well as regulatory affairs staff. The ideal candidate will possess the experience and expertise required to provide regulatory guidance to team members for compliance with DoD, Navy, DHA, and federal regulations.
Serve as subject matter expert on DoD and DHA regulatory policies, requirements, and procedures; Provide guidance to PIs and research staff in the interpretation of applicable regulations and guidelines.
Prepare, develop, review and submit Institutional Agreements, IRB protocol submission, and IRB protocol modifications.
Anticipate regulatory obstacles and emerging issues throughout the research lifecycle and propose solutions and alternatives to Principal Investigators.
Effectively communicate with in-house research teams, external collaborators, regulatory authorities, and administrative staff to facilitate submission, review and approval of regulatory documents.
Track submissions; adequately respond to inquiries and requests; and communicate application progress to internal stakeholders.
Prepare for and participate in internal and external compliance audits.
Remain current on developments in the DoD research and regulatory requirements; Monitor the impact of changing regulations on submission strategies and update internal stakeholders.
A Bachelor’s degree or higher from an accredited university
A minimum of 5 years working in a research environment
Training in Human Subjects Research Protections
Proven expertise and understanding of the federal regulations on human research protection
Candidate must be a U.S. citizen and able to obtain and maintain a Secret Clearance.
Familiarity and training in research methods
Experience as an IRB Administrator or working in a similar position supporting an IRB.
Three or more years working with a military and/or veteran population.
Naval Health West - NHW
Pay Range:Pay Range $65,000.00 - $100,000.00 - $135,000.00
The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
Covid Guidance for the US
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® 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 44,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $13.7 billion for the fiscal year ended December 31, 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.