The Research Health Science Specialist - Human Research Protection Program Manager serves in the Associate Chief of Staff Research and Development (ACOS/R&D). Richard VAMC, Mid-Atlantic Healthcare Network (VISN 6), Veterans Health Administration (VHA), Department of Veterans Affairs, Richmond, VA.

Duties

***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** Duties will include but are not limited to the following: Management of the Human Research Protection Program (HRPP) Performs consultations with the Institutional Review Board (IRB) Administrator and the Research&. Development Committee (R&DC) Coordinator. Retains primary administrative oversight for the HRPP. Safety of Human Research Subjects: Implements the HRPP to safeguard the rights and welfare of human research subjects. Develops local policies and procedures related to the protection of human subjects participating in medical, social, and behavioral research to ensure Researchers, Research Staff, and the Medical Center adheres to all regulations and compliance. Policy and Procedure Maintenance: Assists and/or maintains current administrative policies and procedures. Provides post-approval administrative oversight and audits as determined by committees and/or committee coordinators. Identifies and communicates with appropriate committee coordinator or committee areas for the development of new procedures regarding effective management of the protocol review process and develops procedures and systems for establishing, operating, and assessing the effectiveness of administrative control systems within the HRPP for the purpose of assuring all aspects of human subject protection. Program Effectiveness: Manages productivity and management of the HRPP and develops reporting procedures, sampling techniques, and measurements to identify problem areas or inherent weaknesses in research processes, procedures, information systems, and/or content. Analyzes and evaluates, on a quantitative or qualitative basis, the effectiveness of the HRPP operations in meeting local and established goals and objectives. Analyzes HRPP performance data to identify various issues that may include but are not limited to: human subjects protection, compliance and reporting requirements, human subjects and good clinical practice training requirements, accreditation, committee membership requirements, and Federal wide Assurance FWA) compliance. Multi-Disciplinary Collaboration: Attends all meetings of the IRB, R&D and SRS and may serve as a back-up committee coordinator in the absence of the primary coordinator. Works closely with research office support staff, Information Systems Security and Privacy Officer(s), pharmacy, hospital management, investigators, and research staff. Works closely with the VA Office of Research and Development (ORD), Office of Research Oversight (ORO), Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), VA and other federal or non-federal central/commercial I RBs, and other regulatory agencies in addressing issues pertaining to human research protection program. Compliance and Oversight: Works closely with the Research Compliance Officer (RCO) in maintaining a compliant research program. Works with committee coordinators to promptly report to the research committees, appropriate institutional officials, ORD, ORO, DHHS, OHRP, FDA, and any other sponsoring Federal department or agency head of any unanticipated injuries or problems involving risks to subjects or others. Ensures appropriate oversight mechanisms are in place to maintain compliance with the determinations of the research committees. Educational, Advisory, and Outreach Responsibilities: Develops and implements a dynamic and comprehensive human subjects research protection educational program. Assesses individual learner competency and tailors' educational program to learner's needs. Ensures that the educational program changes with the needs of the organization and is offered to administrators, clinical coordinators, principal investigators, researchers, other support staff, trainees, and students. Provides research training related to research activities regarding national regulatory rules and regulations as well as local policies and standard operation procedures to individuals with ancillary research responsibilities, such as the Privacy Officer, Information Systems Security Officer, Research Pharmacist, local non-profit staff, etc. Advises the R&D Service, IRB, R&D Committee, and investigators on procedural issues, incorporating federal, agency, and local policies. Work Schedule: Monday - Friday; 8:00am-4:30pm Recruitment & Relocation Incentives: Not authorized 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.

Requirements

Qualifications

ENGLISH LANGUAGE PROFICIENCY: In accordance with 38 U.S.C. 7402(d), No person shall serve in direct patient care positions unless they are proficient in basic written and spoken English. You must be proficient in basic written and spoken English in order to meet the requirements of this position. AND BASIC EDUCATION REQUIREMENT: must have successful completion of a full four (4) year course of study in an accredited college or university leading to a bachelor's or higher degree that included a major field of study or specific course requirements related to the medical field, health sciences or allied sciences appropriate to the work of this position. (The number of semester hours required to constitute a major field of study is the amount specified by the college or university attended. If this number cannot be obtained, twenty-four (24) semester hours will be considered as equivalent to a major field of study). (TRANSCRIPT REQUIRED) and ADDITIONAL QUALIFICATION REQUIREMENT SPECIALIZED EXPERIENCE: In addition to meeting the basic education requirement, you must also possess specialized experience and/or additional directly related education to qualify for this position as described below. SPECIALIZED EXPERIENCE GS-11: Must have at least one (1) full year of specialized experience equipped with the knowledge, skill, and ability to successfully perform the duties of the position. This specialized experience must have been equivalent to at least the GS-09 grade level in the Federal service. Qualifying specialized experience include having Mastery of and skills in applying analytical, experimental and/or evaluative methods and techniques to issues or studies concerning the efficiency and effectiveness of program operations in order to ensure the meeting of local and nationally goals and objectives; comprehends pertinent laws, regulations, policies, and precedents in order to interpret or modify the use of program and related support resources in the area studied; human research practices and medical terminology in order to communicate effectively with staff and with healthcare system management, and to understand the objectives, organization and procedures of a large research service; has skills and expertise in adapting analytical techniques and evaluation criteria to the measurement and improvement of program effectiveness and/or organizational productivity; proficient in the Merit review process to understand and facilitate the coordination of just-in-time activities and committee and subcommittee submission and approvals; comprehends the major issues, program goals and objectives, work processes, and administrative operations of the organization in order to facilitate, guide and advise on research activities involving human subjects; conducts detailed analyses of complex functions and work processes in order to evaluate programmatic efficiencies or inefficiencies and develop performance improvement activities related to weaknesses identified; utilizes a variety of computer-based programs and functions for recording and evaluating time and attendance information, creating databases, analyzing data, producing complex documents, researching information required to maintain currency with regulations, procedures and policies, etc. OR SUBSTITUTION OF EDUCATION FOR EXPERIENCE GS-11: having successful completion of a Masters or equivalent graduate degree with a major study in an academic field related to the health sciences or allied sciences appropriate to the position. This education must have been obtained in an accredited college or university. One (1) year of full-time graduate education is the number of credit hours that the school attended has determined to represent one (1) year of full-time study. If that number cannot be obtained from the school, eighteen (18) semester hours should be considered an academic year of graduate study. (Transcripts Required) OR COMBINING EDUCATION AND EXPERIENCE GS-11: Must have equivalent combinations of successfully completed graduate education and Specialized Experience directly related to the work of the position, as outlined for GS-11 above. (Transcript Required) You will be rated on the following Competencies as part of the assessment questionnaire for this position: Critical ThinkingEducation and TrainingResearch IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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. 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; religious; 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. Physical Requirements: The work requires long periods of time working at a computer workstation and interacting with contacts via phone, email, or other electronic communication. Position needs to have good manual dexterity and eyesight. Some slight physical effort may be required such as lifting and carrying for delivery of supplies and documents. Lifting may consist of infrequent duration and a five to ten ( 5 -10lbs) pounds limit. 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

IMPORTANT: 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: Recognition of Foreign Qualifications | International Affairs Office (ed.gov).

Contacts

• Address Central Virginia VA Health Care System 1201 Broad Rock Boulevard Richmond, VA 23249 US
• Name: VHA National Recruitment Center
• Phone: (844)456-5208
• Email: [email protected]