You will serve as a HUMAN RESEARCH PROTECTIONS PROGRAM SPECIALIST in the Research Management Department, Research Services Directorate (RSD) of NAVHLTHRSCHCEN SDIEGO. Salary Range GS-12 $99,044 - $128,752 / GS-11 $82,633 - $107,421

Duties

You will administer and oversee the Human Research Protection Program (HRPP). You will communicate and enforce regulatory/bioethical issues and considerations involved in research activities with human subjects. You will advise researchers in various program areas on the ethics and governance of human subject protection and on human subject regulatory and ethical issues. You will use knowledge of the human subject research regulations to interpret and apply to specific and unique research protocols and situations. You will advise the Institutional Review Boards (IRB) Chair on matters related to research noncompliance. You will provide direct input to the Dept. of Navy (DoN) Human Research Protection Program (HRPP) on updates to Navy-wide human subject research instructions, regulations, and policies. You will manage research proposal and human research protocol triage process, to include the assignment and monitoring of progress of work, ensures appropriate training of administrative staff, and assists staff problem solving. You will develop and maintain meaningful metrics to measure workflow and provides periodic reports to leadership and customers. You will review and approve all new contracts as well as perform annual reviews of contracts for each human use research protocol supported under said contract. You will serve as an institutional Exemption Determination Official (EDO) by reviewing NHRC research proposals for a human subject research determination.

Requirements

• Must be a US Citizen.
• Must be determined suitable for federal employment.
• Must participate in the direct deposit pay program.
• New employees to the Department of the Navy will be required to successfully pass the E-Verify employment verification check. To learn more about E-Verify, including your rights and responsibilities, visit e-verify.gov
• Within the Department of Defense (DoD), the appointment of retired military members within 180 days immediately following retirement date to a civilian position is subject to the provisions of 5 United States Code 3326.
• Males born after 12-31-59 must be registered for Selective Service.
• You will be required to obtain and maintain an interim and/or final security clearance prior to entrance on duty. Failure to obtain and maintain the required level of clearance may result in the withdrawal of a job offer or removal.
• Incumbent must be able to obtain and maintain an appropriate security clearance and be eligible up to Secret level. This position is Non-Critical Sensitive.
• A favorable Tier 3 background investigation is required for all Non-Critical Sensitive (NCS) positions with access to network systems and Personally Identifiable Information (PII).
• Maintain strict confidentiality of human research subjects in accordance with the Health Insurance Portability and Accountability Act (HIPAA).

Qualifications

FOR GS-12 Your resume must demonstrate at least one year of specialized experience at or equivalent to the GS-11 grade level or pay band in the Federal service or equivalent experience in the private or public sector: Utilizing appropriate federal legislation, (e.g., Executive Orders and DOD/DoN/United States Marine Corps (USMC)), regulations governing the use of human subjects in research to analyze, develop and execute long-range programs and plans; Using analytical and evaluative methods to ensure compliance and effectiveness of the Human Research Protection Program based upon statutes, regulations, and guidance; Developing new human subject research processes and/or best practices using federal legislation, (e.g., Executive Orders and DoD/DoN/United States Marine Corps (USMC)), regulations governing the use of human subjects in research that may be adopted by other research commands/organizations within the government, (e.g., DoD) and local agency-wide; Managing research proposal and human research protocol triage process, to include the assignment and monitoring of progress of work, ensures appropriate training of administrative staff, and assists staff problem solving as pertaining to human research protection; Improving administrative policies and procedures which relate to the efficiency of the Institutional Review Boards (IRB) process; Analyzing program details and present facts and recommendations in clear, concise, logical terms both orally and in writing to leadership; AND Assessing the parallel practices of other federal agencies, private industry, academia, and foreign countries in the course of collaborative efforts and as a reference for developing new policies and practices. FOR GS-11 Your resume must demonstrate at least one year of specialized experience at or equivalent to the GS-09 grade level or pay band in the Federal service or equivalent experience in the private or public sector: Applying/implementing analytical and evaluative methods to ensure compliance and effectiveness of a institutional-wide program, (i.e., Human Research Protection Program, based upon statutes, regulations, and guidance; Studying, analyzing, and developing methods to improve the accuracy, adequacy, and timeliness of information for dissemination about the human research protection to a diverse group of people, (e.g., scientists) and members of the Institutional Review Boards (IRB) at many organizational levels and/or geographic locations; Using analytical and evaluative methods to ensure compliance and effectiveness of a Human Research Protection Program based upon statutes, regulations, and guidance; Gathering information, identifying and analyzing issues, and developing recommendations to resolve substantive problems of effectiveness and efficiency of the operations a institutional-wide program, (i.e., Human Research Protection Program); Developing and maintaining a research database to capture approved/non-approved projects; AND Evaluating input, developing organizational goals and objectives for review and validation. Additional qualification information can be found from the following Office of Personnel Management website: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/1800/general-inspection-investigation-enforcement-and-compliance-series-1801/ https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series

Education

SUBSTITUTION OF EDUCATION FOR EXPERIENCE: Applicants may substitute the following education for the required experience, provided it demonstrates the knowledge, skills and abilities necessary to do the work of the position:

FOR GS-11 - Successful completion of Ph.D. or equivalent doctoral degree that is directly related to the position. ((Possession of the requirements must be verifiable via SUBMITTING A COPY of the complete transcripts with your application.) Failure to submit a copy of your transcripts with your application will result in not crediting the substitution of education.

OR

SUCCESSFUL COMPLETION OF Three "3" full years of progressively higher level graduate education leading to such a degree that is related to the position being filled (Possession of the requirements must be verifiable via SUBMITTING A COPY of the complete transcripts with your application.)
Failure to submit a copy of your transcripts with your application will result in an ineligible rating.

OR

LL.M., if related (Possession of the requirements must be verifiable via SUBMITTING A COPY of the complete transcripts with your application.)
Failure to submit a copy of your transcripts with your application will result in an ineligible rating.

Foreign Education: Required for vacancies with Positive Education or Education Substitution: Education completed in foreign colleges or universities may be used to meet the qualification requirements if the applicant can provide documentation indicating that the foreign education is comparable to that received in an accredited educational institution in the United States. It is the responsibility of the applicant to provide such evidence when applying for further information, visit:
http://www.ed.gov/about/officies/list/ous/international/usnei/us/edlite-visitus-forrecog.html

See Required Documents for additional information.

Contacts

• Address NAVHLTHRSCHCEN SDIEGO 140 Sylvester Road San Diego, CA 92106-3521 US
• Name: Department of Navy EIC
• Email: [email protected]