This position is organizationally aligned to the Office of the Hospital Director at the Edward Hines Jr. VA Hospital (578) - a Level 1a Complexity VHA Facility. The primary purpose of this position is to develop, implement, maintain and provide leadership, strategic direction, and oversight of compliance and training activities for the Research Program.
To qualify for this position, applicants must meet all requirements by the closing date of this announcement. 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-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 BASIC REQUIREMENTS: You must have one of the following: EDUCATION: Undergraduate or Graduate Education with a major study in hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration. OR, EXPERIENCE: Progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field? This work may have been performed in an operating health care facility or a higher organizational echelon with advisory or directional authority over such facilities. Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities, and provided knowledge of the following: Missions, organizations, programs, and requirements of health care delivery systems Regulations and standards of various regulatory and credentialing groups Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel, and procurement IN ADDITION TO MEETING THE BASIC REQUIREMENTS LISTED ABOVE, YOU MUST MEET THE FOLLOWING GRADE REQUIREMENTS TO QUALIFY FOR THIS POSITION. GS-12 GRADE REQUIREMENTS: 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: Research-related expert knowledge and experience in performing verifiable research auditing that utilizes accepted national and VA methods for auditing of research projects. Expert knowledge of the major issues, program goals and objectives, work processes, VA policies and administrative operations of the organization. Broad knowledge of quality improvement principles and methodologies used to evaluate programs and the quality of health care delivery. Ability to make oral and written reports and presentations, graphically prepare and present statistics and other data, and develop conclusions, recommendations and actions based on analysis and evaluation in such form and manner that are most useful. Knowledge of advance computer skills, including office software, intranet and internet communication networks (to be able to communicate quickly and efficiently for a variety of administrative purposes.) Knowledge of techniques for leading employee groups to help them achieve new process, conflict resolution and team cohesion. Ensuring R&D program is in compliance in the areas of credentialing, training, and education of investigators and research staff. Collaborating with the Information Security Officer (ISO) and the Privacy Officer in matters related to protection of sensitive and non-sensitive information. Designing and implementing training programs. Providing accurate information in an understandable manner when responding to questions/providing information to Management, Principal Investigators, study staff, clinicians, and others. Working closely with other departments such the Office of Research Oversight (ORO) regarding review of Human Research Protection Program (HRPP) activities. Analyzing and evaluating, on a quantitative or qualitative basis, the effectiveness of programs and operations. Serving as the primary liaison with outside entities concerning compliance issues in accordance with the "common Rule" (45 CFR 46) and other regulations and policies. Reviewing Research Safety, Biosafety, rDNA Subcommittee Activities, and records (including databases and meeting minutes) to ensure compliance with national requirements. Performing ongoing research auditing in assigned areas of responsibility. 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. You will be rated on the following Competencies for this position: Administration and Management Communications Program Management Preferred Experience: Prefer individual with experience evaluating compliance with Federal and VA requirements for the conduct of research, which may include requirements in one or more of the following areas: the protection of human research subjects, laboratory animal welfare, and research safety and security. 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: Work is mainly sedentary. Traveling off station to other sites of care or various meetings is necessary and working overtime and odd hours, to include weekends may be necessary. There may be some walking, standing, bending, carrying of light items, such as instructional material, manuals, papers, and books. 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/.
The Research Compliance Officer (RCO) evaluates compliance with Federal and VA requirements for the conduct of research, which may include requirements in one or more of the following areas: the protection of human research subjects, laboratory animal welfare, and research safety and security. Incumbent may also be assigned responsibilities related to facility programs for research information security, research privacy, conflict of interest in research, training of research personnel. Research program accreditation, research misconduct, and/or other research compliance activities consistent with VHA requirements. As a public agency, VHA has an obligation to preserve public trust in the integrity and quality of research carried out by its investigators, involving subjects in VA research, and in its facilities. Appropriate mechanisms must be in place to evaluate the functioning of the Human Research Protection Program (HRPP) and the safeguards in place to protect human research subjects in VA research. There must also be appropriately trained staff available at each VA facility conducting human subjects' research to audit each research project involving human subjects. The RCO performs ongoing research monitoring and auditing in assigned areas of responsibility. These activities must be consistent with VHA research monitoring and auditing requirements and require the ability to conduct in-depth review and analysis of research, clinical, and training records relevant to the assigned areas of responsibility. Monitoring and auditing reports are timely. accurate, and complete; reports are provided to facility leadership and others in accordance with VHA requirements. Effectively uses Research Service and research review committee information systems such as VAIRRS/IRBNet to complete audits. Uses audit worksheets and auditing tools for the informed consent audits and regulatory audits that incorporate national requirements and may include local requirements. Develops, uses, and maintains spreadsheets or other tools to track audits of facility research. Evaluates results of audits and inspections, and forwards action items to the responsible individual and/or organization (e.g., FDA, ORO, OHRP, VA). Performs audits of research records related to human subject and animal subject protections. Maintains audit records as required for compliance and derives routine analyses of trends from those records. The RCO will document all compliance audits, inspections, and management controls or activities as a record of review. Documentation includes reports of serious or continuing noncompliance findings lo research oversight committees, facility leadership and other oversight entities, as required by law and policy. Through auditing identifies apparent systemic deficiencies that have a reasonable likelihood of substantially compromising the VA medical facility's research protection programs or information security processes and ensures prompt reporting to the relevant research review committees and ensures reporting of determined systemic deficiencies to ORO and applicable federal agencies. The RCO ensures that relevant regulatory and policy updates in assigned areas of responsibility are disseminated to research administrators, research oversight committees, research investigators, research personnel, and facility leadership in a timely manner. Serves as the primary local resource for regulations, policies, memoranda, alerts, and Federal requirements in assigned areas of responsibility and works with research personnel to maintain current and open communication regarding research compliance issues. Serves as subject matter expert to the MFD and the medical center's research leadership team and to all VA researchers to assure compliance with regulations related to human subjects involved in research. The RCO is responsible for effective verbal and written communications with facility leadership, research review committees and staff and with research investigators to advise them on changes and updates in policy matters, process issues, and procedural requirements necessary for conducting audits, as well as externally with Program Office staff such as ORD and ORO. Drafts internal and external reports or other communications at the direction of the MFD. Reviews Federal regulations and actively participates in implementing Federal regulations on Conflict of Interest. Reports any identified conflict of interest to the Financial Conflict of Interest official(s) and MFD as appropriate. Work Schedule: Monday - Friday 7:30 am - 4:00 pm Compressed/Flexible: Not Authorized Telework: This position is not authorized for telework. Virtual: This is not a virtual position. Position Description/PD#: Health System Specialist (Research Compliance Officer)/PD030540