The Northern Arizona VA Health Care System is recruiting for a Research Compliance Officer responsible for coordinating research compliance activities and performing assessment and adherence to established research compliance policies and procedures.

Duties

The Research and Compliance Officer provides guidance and counsel on incorporating compliance-related activities in the day-to-day operation of the research program and is responsible for developing, implementing, maintaining, and providing leadership with strategic direction and oversight of compliance and training activities for the research program at the Northern Arizona VA Health Care System. Duties include but are not limited to: Provides leadership, expertise and strategic direction within the research compliance program Responsible for developing, implementing and maintaining compliance oversight in areas of responsibility Provides guidance and counsel incorporating research compliance activities into the day to day operations of the facility Monitors compliance of research projects conducted through the facility's biomedical research program Prepares information for research activities Participates in monitoring and evaluating overall research program content Assists in the determination of the need for additional ad hoc review/representation from scientific and medical practice specialties. Providing monitoring and auditing reports to facility leadership in a timely, accurate and complete manner. Conducts routing and "for cause" reviews as well as performance improvement activities to promote compliance, reduce violations, identify unsatisfactory trends and conditions, and identify and communicate factors that may contribute to noncompliance. Develops procedures and systems for establishing, operating, and assessing the effectiveness of research compliance control systems and the accomplishments, evaluation, and/or monitoring of audits, inspections, and other reviews as needed. Verifies implementation, control, and reporting on clinical encounters according to R&DC, IRB, SRS requirements. Verifies that data from biological samples and specimens as well as all related use, handling, storage, and disposition tracking data that is organized and projected during the progress of the study. Coordinates and conducts the review and evaluation of on-going compliance in biomedical research programs and provides recommendations or decisions for program strategies, modifications, or improvements. Performs quality assurance activities that involve systemic prevention of nonconformed to regulations and standards. Performs a variety of duties to assure full compliance in each of the five-compliance program human studies, laboratory safety and radiation safety, conflict of interest, information security and privacy. Documents all compliance audits, inspections, and management controls or activities as a record of review. Develops policies, procedures, and criteria for monitoring compliance and assisting researchers in meeting the requirements of the organization's programs in Human Research Protection, Research Safety, Research Privacy and Information Security through continuing evaluation and review. Develops strategy, policy, and/or standards covering the facility's research compliance program activities and records. Provides guidance to others in analyzing research programs and to determine the appropriate kind of review. Promotion Potential: The selectee may be promoted to the full performance level without further competition when all regulatory, qualification, and performance requirements are met. Selection at a lower grade level does not guarantee promotion to the full performance level. Work Schedule: Monday - Friday, 8:00am to 4:30pm Telework: May be authorized for highly qualified candidates Virtual: This is not a virtual position. Position Description/PD#: Health Systems Specialist - Research Compliance Officer/PD142900 Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved 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, 12/28/2023. 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-11 position you must have served 52 weeks at the GS-9. For a GS-12 position you must have served 52 weeks at the GS-11. 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. For a GS-11 You may qualify based on your experience as described below: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-9 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Knowledge and skill in applying analytical and evaluative methods and substantive administrative support functions to issues or studies concerning the effectiveness of the Research Compliance program operations and knowledge of pertinent laws, regulations, policies, and procedures to develop new or modified work methods to conduct audits, investigate issues, resolve problems and evaluate the Research program to ensure compliance for the Medical Center's Research program at the facility level. OR, Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have a Ph.D. or equivalent doctoral degree, or 3 full years of progressively higher level graduate education leading to such a degree, or LL.M., if related. NOTE: If you select this option, you must submit a copy of your transcript with your application. Education cannot be credited without documentation.. OR, Combination: Applicants may also qualify based on a combination of experience and education. Applicants must possess a combination of successfully completed progressively higher-level graduate education (beyond the second year/masters level) and specialized experience, as described above, which meet the total experience requirements for this grade level. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. This education must have been obtained in an accredited college or university. NOTE: If you select this option, you must submit a copy of your transcript with your application. Education cannot be credited without documentation. For a GS-12, you may qualify based on your experience as described below: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade (GS-11) in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Knowledge and skill in applying analytical and evaluative methods and substantive administrative support functions to issues or studies concerning the effectiveness of the Research Compliance program operations and knowledge of pertinent laws, regulations, policies, and procedures to develop new or modified work methods to conduct audits, investigate issues, resolve problems and evaluate the Research program to ensure compliance for the Medical Center's Research program at the facility level. You will be rated on the following Competencies for this position: Compliance InspectionPlanning and EvaluatingResearch 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. However, there is periodic walking; standing; bending; carrying of light items such as medical records, instructional materials, 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.

Contacts

• Address Bob Stump VA Medical Center 500 Highway 89 North Prescott, AZ 86313 US
• Name: Kyle Parker
• Phone: (480)246-0591
• Email: [email protected]