Human Subjects Research Review Official - Washington, District of Columbia

Job Summmary

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.

Who can apply

1. Federal employees - Competitive service
2. The public

Job Duties

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

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

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.

Qualification

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.

Get More benefits details at https://www.epa.gov/careers/salaries-and-benefits

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

This position is being filled through the ST hiring authority. Under the provisions of the ST hiring authority, category rating, veterans’ preference, and traditional rating and ranking of applicants do not apply. We will review your resume and required documents to ensure you meet the basic qualification requirements. All eligible applicants will be forwarded to the Selecting Official for further consideration, and you may be subject to further assessments during the selection process. You may preview questions for this vacancy.

Document Requires:-

Documents to be submitted online: NOTE: You should ensure your social security number, date of birth, and any other personal information are redacted. -- Resume - Required for all applicants - State your experience related to this position as described in the Duties section and Qualifications section. In describing your experience, be clear and specific. We may not make assumptions regarding your experience. -- Technical Qualifications (TQs) - Required for all applicants - Address in a narrative statement each listed factor individually within a limit of two (2) pages per factor. Exceeding this limit will result in disqualification of your application. Your examples should emphasize your level of responsibilities, scope and complexity of programs managed, program accomplishments with results of your actions, policy initiatives and level of contacts. -- College transcripts - Required for all applicants - unofficial or official transcripts or a list of courses that includes school(s) attended, school address, course title, grades earned, completion dates, department, and quarter or semester hours earned. NOTE: Official educational transcripts are not required at the time of application; however, if you are selected, you must provide official transcripts before you start work with EPA. IF EDUCATION WAS COMPLETED AT A FOREIGN INSTITUTION: You must submit an equivalency evaluation with your application as described here: EPA Announcement Policies and Procedures. To learn more about submitting documentation, visit Uploading Documents to USAJOBS.

How to appy this Job

You are strongly encouraged to read the entire announcement before you submit your application for this position. You must provide specific examples of your education, experience, training and awards in the manner and order instructed below which are applicable to each Technical Qualification (TQ). Responses to the TQs are mandatory. Failure to address the TQs will result in your application being disqualified. To begin the application process, click the Apply button to the top right on this screen, follow the prompts to log-in/register, submit all required documents, and complete the assessment questionnaire. To be considered, you must submit a complete application package by 11:59 PM Eastern Time on the day the announcement closes. As referenced in the Required Documents section, all required supporting documents will be collected electronically via the USAJOBS document portfolio feature. It is recommended that you review your application materials after they have been uploaded to your application to ensure they conform to the requirements stated in the announcement. If you have any questions or concerns regarding your application, please contact the HR Specialist listed on the announcement. If you cannot apply online, you must contact the HR Specialist listed below for assistance no later than two business days prior to the closing date of this announcement. You must provide complete application materials by the day the announcement closes. For detailed instructions to assist you in ensuring your application package is received, go to EPA Announcement Policies and Procedures. REASONABLE ACCOMMODATION EPA welcomes applications from persons with disabilities. Through the reasonable accommodation process, we provide persons with disabilities an equal opportunity to enjoy the benefits and privileges of employment that persons without disabilities enjoy. A reasonable accommodation is any change in the work environment or in the way things are customarily done. An accommodation removes workplace barriers and enables an applicant with a disability to have an equal opportunity to participate in the application process, be considered for a position, and, if hired, perform the essential functions of their job. The EPA National Reasonable Accommodation Coordinators will provide assistance to you, the Human Resources Office, and/or the hiring official as needed. For more information, refer to EPA’s Reasonable Accommodation website. Below is more detailed information about how to request a reasonable accommodation during the application, selection, and hiring process: • If you require reasonable accommodation for any part of the application process (submitting the application or completing the application process), contact the Human Resources Office listed below no later than two business days prior to the closing date of this announcement, and the Human Resources Office will work directly with you. • If you are referred to the hiring official for consideration and need an accommodation during the selection process, including the interview, notify the person who contacted you from the hiring official’s office. If you do not hear back within three days about your reasonable accommodation request for the selection process, please notify EPA’s National Reasonable Accommodation Coordinators via email at [email protected]. • If you are selected and need an accommodation during the hiring process up to orientation, notify the HR Specialist who made the job offer to you. Please note: Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

Apply Online

Next Step after Apply

It is your responsibility to check your USAJOBS account for application status information. You can track the progress of your application via your USAJOBS account by clicking the Track This Application link. Your USAJOBS application status will appear in your profile if your application was received successfully; if your submission was not received, the application status will show as unavailable. After the announcement closes, the Human Resources Office will conduct a review of your application package. If your application is complete and you meet basic qualification requirements, it will be forwarded to the Selecting Official for further review of your narrative statements addressing the required TQs. Interviews are arranged through the Selecting Official. If you are selected, you will be contacted personally by the Human Resources Office posting this announcement. Your application status will change in USAJOBS when updates are available for each step of the process. NOTE: We may verify all information you provide in your resume and questionnaire responses through reference and/or background check, and/or verification of your education. Any exaggeration of your experience, false statements, or attempt to conceal information may disqualify you for employment consideration.