Regulatory Affairs Specialist (DoD and DHA compliance)

Description

Job Description:

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.

Position Responsibilities:

• 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.

Required Qualifications:

• 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.

Preferred Qualifications:

• 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:

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.

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