Summary This Scientific or Professional (ST) position is in the Office of Research and Development, Office of Science Advisor, Policy, and Engagement. This is an office-centered position*--you must physically report to the duty station stated in this announcement on a regular basis. *EPA offers work-from-home and work schedule flexibilities as described in the Benefits section. About ORD. Responsibilities This position is located in the Immediate Office of the Office of Science Advisor, Policy and Engagement (OSAPE), in the Office of Research and Development (ORD). OSAPE, under the leadership of its Director, supports the Agency’s Science Advisor and Chief Scientist and integrates and coordinates science across ORD, the Agency, with key external partners, and into the regulatory process. Specifically, OSAPE provides support by: integrating scientific research and expertise into Agency decisions, providing Agency leadership on scientific integrity and human subjects research review and approval, providing advice and vision on science and technology issues, managing ORD’s extramural research programs, serving as ORD’s lead on science policy issues, and coordinating ORD’s partnerships with Tribes, other Federal agencies and international organizations, and State and local partners. OSAPE ensures its products and services support ORD’s and EPA’s mission and strategic vision and comply with Federal laws and regulations. Senior scientists in OSAPE may serve on ORD and Agency councils and committees as necessary pursuant to OSAPE’s functional responsibilities and provide expertise to ORD and the Agency in their specific areas of focus. Additionally, the Office interfaces with other ORD and EPA organizations and other Federal and nonfederal entities concerning OSAPE’s products and services. OSAPE also houses EPA’s Human Subjects Research Review Official (HSRRO). The HSRRO provides Agency leadership regarding the review and approval of human research and oversight of relevant policies, practices, and regulations. The incumbent provides training, consultation, guidance, and leadership, and serves as the expert technical resource on matters related to human subjects research, ethics, and subject safety. The HSRRO provides strategic vision and leadership for EPA on human subjects research. Specific duties of the position include: Overseeing the agency-wide Program in Human Research Ethics and Oversight (PHREO) including ensuring agency compliance with 40 CFR 26, relevant EPA Orders and policies, and PHREO Standard Operating Procedures Manual, and tracking, coordinating, and managing all protocol materials submitted for review. Overseeing the creation and management of systems for tracking, coordinating, and archiving all records related to human research studies, including research protocols, consent forms, questionnaires, advertising, correspondence with the Institutional Review Boards and EPA officials, and staff training related to human studies. Reviewing all protocols, consent forms, and other documentation for human studies for conformance with the Common Rule, EPA policy and any other applicable requirements and providing approvals if all requirements are met. Preparing and delivering training on human ethics policies and procedures for human studies to EPA investigators, staff, managers, and contractors. Developing and implementing policies and procedures that increase public access to results of EPA-funded human subjects research while protecting research participants and their personal identifying information. Providing leadership in developing, evaluating, and continually improving EPA test methods, policies, guidelines, rules, and procedures regarding subject safety and the ethical conduct of human studies including initiation and oversight of periodic external peer reviews of the human subjects research programs and/or selected activities, intramural audits, and other review and improvement efforts. Requirements Conditions of Employment You must be a U.S. citizen. You must submit a resume and required documents--see How to Apply section. Position has education requirements--see Qualifications/Education section. EPA and non-EPA applicants must submit transcripts/course listings. If you are selected, you must complete a one-year probationary period. The Ethics in Government Act, P.L. 95-521 requires the applicant selected for this position to submit a financial disclosure statement, OGE-278, prior to assuming the ST position, annually, and upon termination of employment. This position is designated as High Risk and requires a background investigation. Unless an appropriate background investigation is already on record with the Office of Personnel Management, you must undergo a background investigation. All conditions of the pre-employment security process must be met before an official letter of employment can be issued with a report for duty date. #LI-Onsite Qualifications In addition to the educational requirements, we are looking for: At least 3 years of specialized experience in, or closely related to, the field of oversight of human subjects research studies including developing, implementing, and evaluating policies, procedures, and record-keeping; and At least 1 year of this specialized experience must have been in planning and executing difficult programs of national significance or planning and executing specialized programs that show outstanding attainments in the field of research or consultation; and At least 1 year of the specialized experience must be at least equivalent to experience at GS-15 level. We will review your resume and required documents to ensure you meet the basic qualification requirements. If you meet basic qualification requirements, your application will be further evaluated based on your narrative statements addressing the Technical Qualifications. Your responses should be clear and concise and show a level of accomplishment and a degree of responsibility. Technical Qualifications (TQs) - Mandatory for all applicants - Failure to address these factors individually within a limit of two (2) pages per factor will result in your application being disqualified. TQ 1 - Demonstrated experience managing a program in human research ethics and oversight at a large, diverse, and multi-faceted scientific and regulatory organization. TQ 2 - Demonstrated experience building networks, coalitions, and relationships with a range of federal and non-federal partners related to human research ethics and oversight. TQ 3 - Demonstrated experience overseeing and ensuring the ethical and regulatory compliance of research projects involving human participants, including ensuring compliance with the Common Rule, subparts to 40 CFR 26, and the Belmont Report. Education Biologist: You must have a bachelor's or higher degree from an accredited or pre-accredited college or university in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position; OR a combination of education and experience with courses equivalent to a major, as listed. Health Scientist: You must have a bachelor's or higher degree from an accredited or pre-accredited college or university in the following: major study in an academic field related to the medical field, health sciences or allied sciences related to the work of this position. For information about accreditation requirements, visit EPA Announcement Policies and Procedures. Additional Information If you are selected, travel, transportation, and relocation expenses will not be paid by EPA. Any travel, transportation, and relocation expenses associated with reporting to work in this position will be your responsibility. Time in grade requirements do not apply to ST positions. EPA participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that enables participating employers to electronically verify the employment eligibility of their newly hired employees. For additional information: EPA Announcement Policies and Procedures. Diversity, equity, and inclusion are core values at EPA. Our excellence can only be fully realized by staff who share our commitment to these values. Successful candidates are committed to advancing equity and inclusion in the Agency’s workplace and mission. We encourage applications from candidates with a variety of personal experiences, values, and worldviews that arise from differences of culture and circumstance. At EPA, diversity is a vital element in bringing a balance of perspectives to bear on every challenge we face. We are committed to creating a diverse workforce because we know that the individual strengths and abilities of our employees make us a stronger organization. The more inclusive our employee base is, the greater the variety of ideas that are generated, and the more representative we are of the nation we serve. To learn more about how EPA values and supports our diverse workforce, visit Equal Opportunity Employment at EPA.