Senior Regulatory Affairs Specialist

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Updated: March 17, 2018
Job ID: 213155
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking a Senior Regulatory Affairs Specialist which serves as a research regulatory oversight subject matter expert (SME) and senior policy analyst supporting Research Regulatory Oversight Office (R2O2) within the Office of the Assistant Secretary of Defense for Health Readiness Policy and Oversight (HPR&O) and assists the government to foster and oversee research and development (R&D) activities planned by components of the Office of the Under Secretary of Defense for Personnel and Readiness (OUSD/P&R) and promote policies and procedures that facilitate timely and effective reviews of OUSD (P&R) research and ensure that approved research is conducted in accordance with applicable rules and ethical guidelines to protect the rights and welfare of the participants, including animals, Service members, employees, and their families. In addition to the responsibilities below, this support may include, but it is not limited to, the education and training (web-based, VTC and in-person training) of researchers and reviewers regarding the research regulatory requirements organizational communications (website, information updates, newsletters, routine correspondence); customer communications (guidance for researchers, support and guidance for reviewers, review notifications); regulatory coordination (work with other regulatory offices to coordinate reviews); problem-solving; quality assurance (routine reviews of all stages of the review process); quality improvement; current SOP procedures (maintain and update); compliance, unanticipated problems, and misconduct reviews (investigating and resolving issues).


• Provide program analysis and support for the OUSD (P&R) Assurance granting and oversight process.

• Support the government in conducting reviews of assurance requests, including reviews of standard operating procedures (SOPs), Institutional Review Board (IRB) membership rosters.

• Support the government in conducting Human Research Protection Official (HRPO) reviews, including determination of assurance sufficiency.

• Perform program analysis and support for the quality assurance (QA) initiatives of R202 by:

o Providing timely and effective reviews of protocols, as needed.

o Coordinating with the P&R network of reviewers to address process issues; assist with regulatory interpretation; provide training as needed in new requirements, tools, forms, etc.; and provide other support as needed.

o Conducting formal and informal reviews of the actions taken by research review systems under the purview of the USD (P&R), including IRBs, Human Research Protection Officials, and Exemption Determination Officials (EDOs)

o Supporting the government in the preparation and staffing of the correspondence announcing the reviews and preparing the report findings. If the findings include deficiencies, the contractor shall suggest an action plan to address the deficiencies in the report and follows-up to ensure the deficiencies are addressed in a timely manner.

• Provide program analysis and support for the quality improvement (QI) initiatives of the Research Regulatory Oversight Office.

• Support the government in the development and sustainment of the SOPs for the Research Regulatory Oversight Office and work with OUSD (P&R) sites to develop and maintain their forms and standard operating procedures.

• Provide recommendations for objective measures to be used in the evaluation of efficiency and effectiveness of the SOPs.

• Support the government in management of the OUSD (P&R) headquarters panel that conducts administrative reviews of research that is international, greater than minimal risk, or FDA-regulated.

• Coordinate and facilitate the meetings by providing panel members all necessary materials before the meeting, arranging and attending all meetings, and preparing a summary of the meeting proceedings.

• Provide program analysis and support for the research integrity initiatives of the Research Regulatory Oversight Office and shall assist, develop, and maintain training programs for researchers, reviewers, and institutional officials for:

o Research involving humans as subjects

o Research involving animals as subjects

• Track training completion for required training.

o Develop and post guidance information and tools for the user community for Regulatory Oversight Office’s website.

• Assist government with investigating and resolving unanticipated problems and allegations of noncompliance or research misconduct.

• Provide support Service working groups, policy reviews, and data calls.

• Coordinate and facilitate reviews, data calls, and requests for comments by:

o Distributing the documentation to be reviewed to the participants, sending reminders and collecting comments, organizing the comment review with the Program Manager, and completing the comment matrix or other documentation, as required.

• Maintain routine organizational documentation including:

o Maintain documents according to the document management plan.

o Develop and distribute newsletters and routine information updates for and to the regulatory research office stakeholder communities.

o Maintain and track effective dates of Memorandum of Agreement and Institutional agreements for EIRB review.

• Provide support for the Electronic Institutional Review Board (EIRB):

o Coordinate and facilitate the meetings by providing panel members all necessary materials before the meeting, arranging and attending all meetings, and preparing a summary of the meeting proceedings.

o Develop a centralized process for EIRB users, including the following types of information:

Training and helpful hints for using the online system

Tracking milestones and general system updates

Connections with research oversight guidance and information

o Analyze the output of system information to create requested presentations of the data to meet specific management requirements.

o Advise the government program manager and senior leaders of system status in accordance with established DoD policies and strategic guidelines.

o Assist the government program manager with tracking program system requirements and needed documentation to maintain accreditation and functionality of the system.`

EDUCATION:  Master's degree is desired in relevant field (any science which routinely uses human or animal subjects in research). Bachelor's degree is desired and 4 additional years of experience may be substituted for master's degree. Current professional certification appropriate to research, such as Certified Institutional Review Board Professional (CIP), is required.  High School diploma and ten years of experience in research regulatory oversight activities is equivalent to a master’s degree.

EXPERIENCE:  Examples of specialized experience include but are not limited to: experience in records management and file plan compliance; database management; reviewing research submissions to ensure completion; monitoring and tracking of documentation to ensure timely processing; communicating with customers regarding administrative issues; drafting and sending correspondence; coordinate preparation for and attend meetings; prepare documents in Excel, PowerPoint, and Word, managing research integrity and/or research compliance programs; working with and/or managing institutional review boards;  providing guidance in HIPAA/privacy policy implementation and compliance; drafting, evaluating, and implementing human research protection program policies; regulatory compliance auditing and assisting in research misconduct investigations/adjudications.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.