Health Science Specialist - Research

Full Job Description

The Health Science Specialist - Research Position is located in the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Mid-Atlantic Health Care Network (VISN 6) at the Richmond, Veteran's Affairs Medical Center (VAMC), Richmond, VA.

The position is organizationally aligned in the Research and Development Service under the general supervision of the Research and Development Administrative Officer (AO).

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 - IN ADDITION TO THE BASIC EDUCATION REQUIREMENT YOU MUST MEET ONE OF THE FOLLOWING.

SPECIALIZED EXPERIENCE GS-11: Specialized Experience: You must have at least one (1) full year of specialized experience equivalent to at least the next lower grade level (GS-9) in Federal Service that has given you the knowledge, skills, and abilities required to successfully perform the duties of a Health Science Specialist- Research.

Specialized experience includes developing and implementing policies, procedures, and criteria for the administration of a health science research program; acts as a liaison between research and Institutional Review Board (IRB); develops and implements human subjects educational program; collecting data and monitoring protocols as they apply to a wide range of clinical studies; and providing technical guidance to research staff regarding regulations, policies, and procedures applicable to the conduct of research NOTE: Your experience must be fully documented in your resume and must include job title, duties, month and year start/end dates AND hours worked per week.

-OR- SUBSTITUTION OF EDUCATION FOR EXPERIENCE GS-11: You may substitute specialized experience with education if you have a Ph.D.

or equivalent doctoral degree or three (3) full years of progressively higher level graduate education leading to a Ph.D.

This education must demonstrate the knowledge, skills, and abilities necessary to do the work of the position such as medical field, health sciences or allied sciences appropriate to the position NOTE: You must submit a copy of your transcript with your application.

Education cannot be credited without documentation.

-AND- Combination: Equivalent combinations of successfully completed graduate-level education and professional experience, as described above, may also be used to meet the total experience requirements for this position and grade level.

The education portion must include graduate courses directly related to the work of this position.

NOTE: Your experience must be documented in your resume and transcripts are required at the time of application.

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/.

Major Duties:

***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION*** The functions involve day-to-day management of the Human Research Protection Program (HRPP).

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 Critical Skills Incentive (CSI): Not approved Telework: This position may be authorized for telework.

Telework eligibility will be discussed during the interview process.