Job opening ID
Roles and responsibilitiesMust be a US Citizen
W2 contract position with full benefits
Must be able to pass background and drug tests
National Institutes of Health, Office of Intramural Research
Office of the Director
Building 10, Room 2C-146
Bethesda, MD 20892
• Serve as a health science policy analyst, specializing in human subjects research; develop and write policies within the Office of Human Subjects Research Protections (OHSRP), NIH Human Research Protection Program (HRPP).
• Analyze new and complex national and international guidelines, regulations, guidance documents; identify emerging issues that impact the protection of human subjects and communicate information to NIH officials, researchers and committees, particularly to the Human Subjects Research Advisory Committee (HSRAC) and IRB-Professional Administrators Committee (I-PAC); ensure that NIH policies, procedures and practices are consistent with guidance issued by DHHS so that NIH can provide comments for proposed national policies; establish and evaluate the processes for implementation of such analysis to ensure compliance throughout the HRPP.
• Work with OHSRP staff to manage reporting of Unanticipated Problems to the DHHS Office of Human Research Protections.
• Work with OHSRP staff on evaluating and developing agreements with other institutions for collaborative human subjects research.
• Serve as an education specialist for the NIH HRPP; develop materials to implement SOPs for the NIH HRPP; lead training sessions for the NIH research community.
• Participate in NIH-wide committees, taskforces and focus groups to seek input from subject matter experts; ensure that proposed policy changes encompass best practices while meeting the varied needs of the research community and foster consensus in the development of criteria for policy and procedures when controversial policy changes must be implemented, e.g., require a new class of employees to undergo ethics clearance.
• Promote greater compliance across institutes by engaging key stakeholders and leveraging their ability to champion regulatory/policy requirements, e.g. clinicaltrial.gov registration and reporting; prepare recommendations to the NIH DDIR and the Director, OHSRP, resulting from the work of these groups.
• Identify and collect necessary program data and conduct interviews with senior officials to obtain information for reports; assemble and assess information gathered; formulate findings, conclusions and recommendations; present results in written and/or oral form, which express the particular human subject’s issue; prepare reports.
• Evaluate the strengths and weaknesses of the NIH HRPP to enhance regulatory compliance; develop policies and procedures for the evaluation of the NIH HRPP program for the purpose of improving human subjects training and educational programs for NIH staff and IRB members.
• Assist with NIH work to create electronic systems for NIH wide document management required for human subject’s protection regulatory compliance; perform gap analysis and define system specifications; ensure that new systems reduce barriers to communications, meet reporting requirements to regulatory bodies such as OHRP and the FDA, engage the broadest possible audience and are platform neutral.
• Develop systems specifications that assist in eliminating barriers to compliance and resistance to change; consider use of various communication tools such as Frequently Asked Questions (FAQ) database, common terminology glossary, web-based training, and other tools to assist NIH investigators and IRB members to comply with HRPP policies and procedures; coordinate all aspects of such development projects with CIT and OIT.
• Work products and documents related to serving as health policy analyst; develop and write policies; analyze national and international guidelines, regulations, and guidance documents; identify emerging issues; establish and evaluate processes.
• Work products and documents related to managing reporting of Unanticipated Problems; evaluate and develop agreements with other institutions; serve as education specialist; participate in committees, taskforces and focus groups.
• Work products and documents related to promoting greater compliance across institutes; identify and collect program data; conduct interviews; assemble and assess information gathered; formulate findings, conclusions and recommendations; present results.
• Work products and documents related to evaluating strengths and weaknesses of NIH HRPP; assist with work to create electronic systems for NIH wide document management required for human subject’s protection regulatory compliance; perform gap analysis and define system specifications.
• Work products and documents related to developing systems specifications that eliminate barriers to compliance and resistance to change; coordinate all aspects of development projects with CIT and OIT.
• Bachelor’s or Master’s degree in Health Sciences, Public Policy, Law or a related discipline.
• Minimum of nine (9) years of experience in policy, legislative affairs or a related discipline.
• Strong communications skills, both oral and written.
• Strong editorial skills.
• Extensive experience with Excel and spreadsheet or database development.
• Strong IT (website) capabilities.
• Excellent analytical, organizational, project management skills.
• Ability to independently manage multiple time-sensitive projects.
• Ability to multi-task and pay close attention to detail.
• Excellent judgment with the ability to determine which decision and actions require guidance from senior staff and which actions can be taken independently.
Number of positions