Serve as the Research Compliance Coordinator for the South Texas Veterans Health Care System (STVHCS) Research Compliance Program. The STVHCS is a diverse and complex teaching facility, affiliated with the University of Texas Health Science Center at San Antonio (UTHSCSA).

Duties

The Research Compliance Coordinator is an integral part of the research compliance program coordinating, monitoring/auditing and executing guidelines; reporting findings and discrepancies to the Research Compliance Officer (RCO). The coordinator must have extensive knowledge of a wide variety of Federal, VHA, and local policy/guidelines to ensure compliance; it is critical in the performance of the duties of this position to ensure accurate reporting of compliance issues to all appropriated research oversight entities involved in, but not limited to those in the areas of: Human subject protection, animal research, conflict of interest, accreditation status, credentialing and privileging, training of research personnel, research safety, privacy and security. Develop and utilize Excel spreadsheets to maintain an accurate master list which accounts for, tracks, and stores data on all active research protocols at STVHCS. Possess specialized skills and abilities to identify, manipulate, sort, and maintain accurate information to ensure all research protocol auditing activities meet reporting requirements as outlined by the Office of Research Oversight. Responsible for coordinating and scheduling all auditing activities for the research compliance program in adherence to ORO guidelines. This includes annual informed consent audits, triennial regulatory audits, and closeout audits. Knowledge of auditing guidelines and annual program reporting requirements to ensure accurate and complete collection of all data to facilitate meeting yearly data reporting requirements to ORO through the Facility Director's Certification of Research Oversight. Develop and implement review/audit tools and audit scheduling letters. Reviews, analyzes and edits audit tools and processes regularly to ensure compliance and recommend changes with current policies, regulations, and guidelines. Conduct informed consent audits on a wide variety of research protocols to verify that each research subject is consented in accordance with Federal, VHA, and local policies/regulations. Prepares final reports of findings from those audits, and follows up with study sites to ensure loop closure. Conduct audits of the Research Pharmacy in conjunction with protocol audits to assess management of investigational drugs. Accurately collect, record and maintain data points from auditing activities in appropriate files on computer shared drive. Administers audits and compiles statistical data to provide detailed information to RCO for monthly reporting to applicable committees, annual Facility Director's Certification of Research Oversight and all documentation reporting requirements. Responsible for maintaining all research compliance protocol files for the program ensuring all auditing activity and applicable regulatory documents are filed appropriately and subsequently archived; and overall records are maintained in a manner that would support compliance of the research compliance program when reviewed by oversight organization(s). Provides oversight to ensure compliance to policy(s) which govern reporting of serious adverse events and/or apparent serious or continuing noncompliance and reports such findings to the RCO in a manner that facilitates the RCO in making timely reports of all such findings to the appropriate committees and leadership. Remain current and maintain awareness of new developments and changes in policies, regulations and/or guidelines governing research compliance and recommend revisions of the technical aspects of research compliance program. Serve as a subject matter expert on regulatory matters, must be able to communicate and implement regulations, and monitor compliance requirements by providing accurate information. Investigate complaint or allegation of noncompliance in the STVHCS research program for appropriate reporting to RCO and maintain same in a protected database for corrective action. Conduct compliance reviews and assessments and report to the RCO. Serve as a Health Insurance Portability and Accountability Act of 1996 (HIPAA) resource for research matters. Perform other duties as assigned. Work Schedule: Monday - Friday, 8:00-4:30pm 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#: Program Specialist (Research Compliance Coordinator)/PD036620 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, 12/21/2023. 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-9 position you must have served 52 weeks at the GS-7. 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: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-7 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: developing excel Spreadsheet(s) to maintain an accurate master list which accounts for, tracks and maintains data on all active research protocols; auditing; scheduling all auditing activities for the research compliance program, ensuring the program is adhering to a schedule in compliance with ORO guidelines for yearly auditing requirements; knowledge of policies, regulations and guidelines pertaining to research compliance and has the ability to review and understand a wide variety of uniquely designed and complex research protocols, understand study design, inclusion/exclusion criteria, sequence of study visits and protocol regulatory documents; communicate effectively with principal investigators and study staff to ensure sufficient priority is given to the scheduling and conduct of required auditing activities; querying Principal Investigator each year, for each active protocol, to determine status; writing and computer skills; organizational skills and attention to detail necessary for maintaining all research compliance protocol files ensuring all auditing activity is filed appropriately and maintained in a manner supporting compliance of the program when reviewed by oversight organization(s). Knowledge and ability to use the hospital computer system and a working knowledge of personal computers with special emphasis required in working in a Windows environment. OR, Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have a master's or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related. (TRANSCRIPT REQUIRED) OR, Combination: Applicants may also combine education and experience to qualify at this level. You must have an combination of specialized experience and education beyond one year of full-time graduate education. (TRANSCRIPT REQUIRED). You will be rated on the following Competencies for this position: Attention to Detail Auditing Compliance Inspection Integrity/Honesty Interpersonal Skills 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. Some work may require movement between offices, hospitals, warehouses, and similar areas for meetings and to conduct work. Work may also require walking/standing, in conjunctions with travel to and attendance at meetings and/or conferences away from the work site. Incumbent may carry and lift light items weighing less than 15 pounds. 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.

Note: If your school has changed names, or is no longer in existence, you must provide this information in your application.

Contacts

• Address Audie L Murphy Memorial Veterans Hospital 7400 Merton Minter Boulevard San Antonio, TX 78229 US
• Name: VISN 17 SSU USAS Group
• Email: [email protected]