DoD Human Research Protection SME 3

Summary

The DoD Human Research Protection SME 3 for the Office of Research Protections (ORP) shall support the DHA ORP Director for human subjects’ protection and research integrity and misconduct programs. The branch promotes policies and procedures that facilitate timely, effective reviews of human subject research along with research integrity and misconduct to ensure that research is conducted IAW applicable rules and ethical guidelines. The support for the ORP office may include, but not be limited to, expertise in compliance with Federal and other regulations/directives.

Responsibilities

• Serve as the subject matter expert for human research protection program regulations, policies, and guidelines and provide industry best practice solutions to extremely complex problems being addressed.
• Assist with day-to-day operations of the DHA Human Research Protection Program (HRPP) Office.
• Monitor and provide timely responses for emails in the HRPP group email inbox and consult with the ORP’s government personnel.
• Formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects’ research, including regulatory coordination (work with other regulatory offices to coordinate human subjects’ protection reviews) as required.
• Maintain electronic filing system for ORP. Provide regulatory-based written -review of protocol life cycle actions following an ORP-required format using standardized checklists. This may include, but not limited to, review of determinations, pre-reviews, IRB reviews, amendments/addenda, administrative or component level or human research protection oversight reviews, continuing review reports, reports of unanticipated problems and serious adverse events, reports of serious or continuing noncompliance, reports of research suspension/termination, protocol deviations, subject complaints, and final study reports and provide a professional quality written review for select Center of Excellence research under DHA oversight.
• Provide guidance to researchers for other reviews necessary beyond HRPP for their research. This may include, but not limited to, privacy office for data sharing agreements and Health Insurance Portability and Accountability Act (HIPAA) reviews, survey, Cooperative Research and Development Agreement (CRADA), etc.
• Technical assistance in revising or drafting electronic filing system processes, policies, and training Perform any functional requirements for standing-up complex enterprise-wide electronic filing system.
• Conduct administrative or component level or human research protection oversight reviews for human subject research protocols.
• Support executive committee and subcommittees for electronic filing system for strategic planning along with Program Office.
• Develop and present standardized educational programs on ethical and regulatory issues through web-based courses that can be tracked through electronic filing system.
• Prepare HRPP briefing slides and formal coordination of official memorandum through correspondence and task management system.
• Interface with DHA Military Medical Treatment Facilities (MTFs) research sites on an ongoing basis. Provide consultation to assist MTFs that fall under DHA ORP oversight to develop and update their human subjects’ protection policies, procedures, guidelines, templates, and review checklists to ensure regulatory compliance with current laws, regulations, and policies governing human subjects’ research.
• Calculate, compile, and submit metrics for HRPP performance measures.
• Facilitate information flow and act as a liaison between research review boards and Federal and Contractor Principal Investigators, research staff, and administrative staff.
• Support HRPP in conducting institutional site assessment visits (SAVs) and assurance requests, including reviews of standard operating procedures (SOPs) and IRB records.
• Develop and coordinate organizational communications (website, information updates, newsletters, routine correspondence).
• Provide support to ensure compliance of DHA research programs with applicable federal, state, and local regulations and DoD requirements for human subject research and research involving recombinant
• Develop a business process for the electronic filing system for HRPP documentation including Institutional Review Board (IRB) reviews and HRPP determinations, pre-reviews, and regulatory reviews.
• Establish standard operating procedure for agreement processing for HRPP.
• Developing and revising policy guidance, management plan, processes, trainings, and agreements for other programs under the preview of ORP including but not limited to Research Integrity and Misconduct (RIM) program.
• Facilitating and participating in interviews with investigators, study staff, IRB staff, and institutional officials and conduct detailed policy and regulatory record reviews and assist with preparation of after-action reports.
• Update internal and external communication forms and respond to DoD taskers.
• Develop policies including SOPs for the HRPP oversight office and work with components to develop and maintain their guidance documents, information papers, and checklists.
• Submit written findings for each assigned Human Research Protection Official review to the HRPP.
• Customer/Client Focus with an emphasis in problem solving and resolution.
• Communicate effectively with researchers, faculty, and other research personnel, management, the HRPP/IRB staff, and the general public.
• Support in the preparation, facilitating and participating in interviews with investigators, study staff, IRB staff, and institutional officials, to local, regional, or National SAVs as needed. Perform close-out assessments with findings and assurance renewal memorandums and make recommendations for improvement.
• Other duties as assigned.

Qualifications

• Bachelors’ degree in a related scientific discipline
• Minimum ten (10) years related HRPP experience OR
• Master’s degree in a related scientific discipline
• Minimum six (6) years of related HRPP experience OR
• PhD in a related scientific discipline
• Minimum three (3) years related HRPP experience
• Certified IRB Professional (CIP), Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) preferred.

Knowledge, Skills and Abilities

• Experience within the DoD healthcare systems preferred.
• Ability to conduct pre-reviews for research involving human subjects and make preliminary determinations and forward recommendations to the COHRP.
• Ability to conduct reviews of HRPP policy guidance or procedural instructions and HRPP checklists.
• Knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule.
• Ability to demonstrate comprehensive knowledge in human research protection and assist the Human Protections Administrator (HPA) with oversite of research involving recombinant deoxyribonucleic acid (DNA).
• Knowledge and understanding management and administrative principles and practices; with the ability to work with committees, manage multiple complex administrative tasks, and prioritize responsibilities.
• Ability to conduct regulatory reviews for the post-IRB approval lifecycle management of research including new studies, continuing reviews, amendments, unanticipated problems involving risks to subjects or others, serious adverse events, continuing noncompliance, serious noncompliance, research suspensions, research terminations, protocol deviations, investigations and audits of DHA human subject research, and study closures.
• Good written and oral communication skills
• Ability to work well in teams.
• Proficiency with Microsoft Office Suite.
• Ability to function independently and proficiently with minimal oversight drawing upon excellent time management and prioritization skills.
• Ability to conduct sire assessment visits (SAVs) for assurance requests, including reviews of standard operating procedures (SOPs) and IRB records upon request of DHA HRPP.

Physical Demands (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee may use repeated motions that include the arms, wrists, hands and/or fingers. The employee is occasionally required to walk, stand, climb, balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.