VA San Diego Healthcare System is recruiting for a Health Science Specialist (Research Compliance Officer). The Research Compliance Officer is responsible for the planning, implementation and oversight of a compliance program for the Research Service.

Duties

Major duties include, but are not limited to: Works closely with the facility Research Administration to ensure the ethical conduct of research for all VA, non-profit, and academic affiliate projects involving human subjects. Serves as the primary liaison concerning compliance issues in accordance with the "Common Rule". Conducts a QA/QI program for the HRPP program to ensure that the research program adheres to NCQA, ORO, and ORD standards. Develops appropriate audit tools and conducts quarterly audits of the HRPP program, including informed consent audits, protocol audits, investigational device audits, investigational drug audits and verification that all research is approved prior to commencement of the research project. Works closely with the Biosafety Subcommittee of the Research and Development Committee and Radiation Safety to ensure that annual laboratory self-inspections are completed, and deficiencies corrected, and that any biosafety issues are identified on proposals for review submitted by investigators. Ensures that Research at the facility is well-prepared for site visits and/or inspections from agencies such as VA ORO, FDA, OHRP, OLAW, FDA, Nuclear Regulatory Commission (NRC}, Inspector General (IG), General Account Office (GAO), Occupation Safety and Health Administration, (OSHA), AAALAC, NCQA, or VACO Research & Development among others and that responses to the above accreditation, regulatory, and inspecting agencies are coordinated with the ACOSJR; COS, Chief Compliance Officer, and Medical Center Director. Work Schedule: Monday - Friday; 8:00am - 4:30pm Telework: VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process. Virtual: This is not a virtual position. Position Description/PD#: Health Science Specialist (Research Compliance Officer)/PD08794O Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Financial Disclosure Report: Not required

Requirements

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 08/24/2023. Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-13 position you must have served 52 weeks at the GS-12. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience and/or education as described below: This position has an INDIVIDUAL OCCUPATIONAL REQUIREMENT (IOR): Education: Must possess a Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education(external link) at the time the degree was obtained (TRANSCRIPT REQUIRED). AND Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-12 in the normal line of progression for the occupation in the organization. Specialized experience includes but is not limited to: coordination and oversight of a research compliance program; expert knowledge of research regulations related to human subjects, biosafety, and information security; conducts regular audits of the research program; verifies all research is approved prior to commencement of research project; ensures compliance with necessary programs, policies, and procedures; identifies, reports, and corrects problems related to the ethical conduct of research. (This experience must be documented in your resume.) You will be rated on the following Competencies for this position: CommunicationsComplianceResearchStrategic Thinking Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Note: A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Physical Requirements: The work is sedentary. Typically, the employee may sit comfortably to perform portions of the work. However, there is periodic walking, standing, bending, carrying of light items such as medical records, instructional material, books and manuals. No special physical demands are required to perform the work. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.

Education

A transcript must be submitted with your application if you are basing all or part of your qualifications on education.

Note: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.

Contacts

• Address San Diego VA Medical Center 3350 La Jolla Village Drive San Diego, CA 92161 US
• Name: Jamie Palazzolo
• Phone: 5628268000 X4660
• Email: [email protected]