Description
Summary The Research Compliance Officer (RCO) is responsible for the coordination of research compliance assurance processes and the education/training of research personnel with regard to research compliance. Through assessments and audits, the RCO will ensure that research conducted by the facility meets the standards and expectations for protection of human subjects, biosafety/biosecurity, and research information security that are defined by Veterans Affairs (VA) and other Federal requirements. Responsibilities Duties include but are not limited to: Serves as the subject matter expert to the medical center's research leadership team and all VA researchers to assure the protection of human subjects involved in research with regard to safety and misconduct. Consults with research coordinators and investigators to provide suggestions for improvements and modifications to submissions and/or practices. Provides professional consultative service to the Chair, Institutional Review Board (IRB), and research investigators involving the application of established principles, theories and concepts for exempted/expedited submission, amendments, continuing progress reports and adverse events. Identifies, develops and disseminates audit tools and mechanisms to assure compliance with Veterans Affairs (VHA, ORD, ORO, OIG), Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), Office of Human Research Protections (OHRP), Food and Drug Administration (FDA), Occupational Health and Safety Administration (OSHA), and other Federal and state regulations applicable to research. Conducts regular research protocol audits to determine that compliance with all applicable policies and regulations are being followed and reports findings to responsible research entities for action. Serve as a local resource for regulations, policies, memoranda, alerts, and other VA and federal requirements related to research compliance. Verifies implementation, control and reporting on clinical encounters according to HRPP and IRB requirements to include monitoring protocols of difficult and complex research studies. Assesses appropriateness of candidates enrolled in research projects based on several factors; such as eligibility according to study protocol, execution of informed consent, and compliance with research guidelines and regulations. Ensure prompt reporting in accordance with all applicable policies to the Office of Research Oversight (ORO), OHRP and FDA (where applicable). Responsible for the ongoing development and maintenance of the HRPP training program encompassing both nationally mandated training requirements and local training initiatives. Works with the VA IRB office in assuring that staff involved with human subject research are current on all required training and provides education to staff as required. Work Schedule: Monday-Friday 07:30AM - 4:00PM, 08:00AM-4:30PM Telework: Not Available Virtual: This is not a virtual position. Position Description/PD#: Health Science Specialist/PD014780 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized Requirements Conditions of Employment You must be a U.S. Citizen to apply for this job Selective Service Registration is required for males born after 12/31/1959 You may be required to serve a probationary period Subject to background/security investigation Selected applicants will be required to complete an online onboarding process Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details. Qualifications To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 05/12/2022. 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-09 . 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. Basic Individual Occupational Requirements: You must first meet Basic Education Requirements for this position as described below. Transcripts are REQUIRED. You must possess a Bachelor's degree (or higher) from an accredited college or university in a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of a Health Science Specialist. Copies of transcripts are required at the time of application. 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-09 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: implementing data collection and monitoring protocols for difficult clinical research studies; administering or monitoring administration of tests and measurements required by project design; recording data from samples and specimens to ensure that all tracking data is organized and is monitored during the progress of the study; adhering to regulatory and local administrative policies for study approvals and reviews, coordinating internal and external audits, performing informed consents, and maintenance of all study and regulatory records. This position also requires experience with preparing project statistical reports for multiple review processes, coordinating the accomplishment of the scientific (merit) review and evaluation of research programs to provide recommendations or decisions for program strategies, modifications, budgeting, or improvements; participating in initial classification and coding of qualitative/quantitative data and entering coding data into qualitative/quantitative software; participating in activities preparing for, and subsequent to, collection of study data; assisting with data analysis from a variety of sources, including databases and spreadsheets, and conceiving and writing reports as needed. You will be rated on the following Competencies for this position: Education and TrainingInformation ManagementProject ManagementTechnical Competence 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 primarily sedentary with occasional walking, standing, and handling and carrying item such as paper and books. There may be occasional need to assist study participants with mobility to study location(s). For more information on these qualification standards, please visit the United States Office of Personnel Management's website at Education There is no educational substitution at this grade level. 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: 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: Additional Information Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. VA may offer newly-appointed Federal employee's credit for their job-related non-federal experience or active duty uniformed military service. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed. Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A..... click apply for full job details
