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
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.
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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.
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Join EPA in protecting human health and the environment and enjoy many work life quality options! Working for the EPA offers you a comprehensive benefits package that includes, in part, 26 days of paid vacation, sick leave, holidays, life insurance, health benefits, and participation in the Federal Employees Retirement System. To learn more about us, visit Life and Careers at EPA.
This position has portable work. If selected for this position, you may be authorized to telework after meeting eligibility requirements if approved by the supervisor/manager. Telework is available based on agency policy.
PUBLIC SERVICE LOAN FORGIVENESS (PSLF): As a federal employee, you may be eligible for student loan forgiveness under the Public Service Loan Forgiveness program. The PSLF program forgives the remaining balance on federal Direct Loans after you have made 120 qualifying payments while working full-time for a qualifying employer, including EPA. Learn more: pslf.gov
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How to Apply
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 disabilityaccommodations@epa.gov.
• 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.
Next steps
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.