Clarification from the agency

ALL US CITIZENS DIRECT HIRE AUTHORITY: This position is being filled using Direct-Hire Authority (5 CFR 337.201) for this occupation.

The Research Committee Manager position is vital within the ORD and the facilities where research programs are conducted. Research Program Managers provide the link between Veterans and highly innovative projects. Duties and responsibilities include but are not limited to:

R&D, IRB, IACUC, SRS, CIRB, IBC, and/or HRPP Program Administration

• Oversees and manages these programs and their activities, including preparation of committee and reviewer materials with appropriate documentation, ensuring projects are reviewed by appropriate personnel, and ensuring all outstanding issues related to project management are resolved in a timely manner.

• Serves in an advisory capacity to the R&D Leadership, research investigators, research committee members, and research committee Chairs and others on issues relative to carrying out the institution's research activities involving the use of humans, animals, and safety procedures for investigative purposes.

• Serves as the accreditation Facility Liaison.

• Oversees the protocol review process of multiple programs and committees, ensuring projects are reviewed by appropriate personnel, including the Information System and Security Officer (ISSO) and Privacy Officer (PO), and issues related to project management are resolved.

• Develops and maintains a pre-review program that will coincide with the IRB, IACUC, SRS, IBC, CIRB, and/or R&D Committee review of all research involving human subjects, animal subjects, basic laboratory science and the human research protection program.

• Develops and manages required annual and semi-annual reviews of the assigned programs.

• Stays informed on guidelines relating to security and safety in the conduct of research and advises Research and Safety leadership, as needed.

• Educates the investigative community of local and external policies and procedures with regards to research involving animal and human subjects.

• Develops reporting procedures, sampling techniques, and measurements at various points in the research committee process and research programs to identify problem areas or inherent weaknesses in work processes, procedures, information systems and content.

Quality and Compliance

• Responsible for maintaining the federal-wide assurance with the Office of Human Research Protection and ensuring IRBs are appropriately constituted and registered.

• Responsible for maintaining the IBC registration with the National Institutes of Health Office of Science Policy and ensuring IBC is appropriately constituted and registered.

• Responsible for maintaining the program's accreditation process for the Association for the Assessment and Accreditation for Laboratory Animal Care International (AAALAC).

• Analyzes and evaluates each research project to ensure compliance with Federal and State regulations, including but not limited to VA, FDA, OHRP (Office of Human Research Protection), ORO, and other applicable regulatory and procedural requirements.

• Develops programs, policies, and procedures within the Research.

• Monitors quality assurance program implementation and indicators designed to prevent erroneous transactions and ineffective work practices and to verify adherence to quality assurance plans and requirements.

• Responsible for alerting investigators of deficiencies found within their submissions and educating them as to the steps required to correct the deficiencies.

Administrative Oversight

• Assumes responsibility in preparing for all external reviews.

• Research and/or analyzes problems, administrative issues, or program requirements as they relate to animal, human subject or safety research and the research review process.

• Initiates or reviews correspondence for all research.

• Oversees and refines customized, networked computerized databases to allow for timely tracking of research projects.

• Serves as the electronic records system administrator for the Research Office.

Work Schedule: Monday - Friday, 8:00am - 4:30pm
Telework: Ad -hoc
Position Description Title/PD#: Health System Specialist - Research Committee Manager/PD99586S
Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. Work is typically performed in an adequately lighted and climate-controlled office. May require occasional travel.

Conditions of employment

• You must be a U.S. citizen to apply for this job
• Subject to a background/suitability investigation
• Selective Service Registration is required for males born after 12/31/1959
• A complete application package; Resume, Transcripts, etc. is required
• Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents).
• Effective May 7, 2025, driver's licenses or state-issued identification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.

Upon completion of your probationary period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.

As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider:

• your performance and conduct;
• the needs and interests of the agency;
• whether your continued employment would advance organizational goals of the agency or the Government; and
• whether your continued employment would advance the efficiency of the Federal service

Qualifications

To qualify for this position, applicants must meet all requirements by the closing date of this announcement.

Specialized Experience: You must possess at least one (1) full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a Health System Specialist - Research Committee and provided you with knowledge of the full scope of activities required to conduct single and multisite research in the areas of human subject protection, biosafety, Institutional Review Boards (IRB), Institutional Animal Care and Use Committees (IACUC), and R&D Committees through regulatory and policy compliance. To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-9) in the normal line of progression for the occupation in the organization. Specialized experience includes 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: (a) Missions, organizations, programs, and requirements of health care delivery systems; (b) Regulations and standards of various regulatory and credentialing groups; (c) Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel and procurement; and knowledge of cognitive engineering, human factors engineering, human-computer interaction, or related fields.

OR

SUBSTITUTION OF EDUCATION (Transcript Required) -Successfully completed a Ph.D. or equivalent doctoral degree, three (3) full years of progressively higher level graduate education leading to such a degree, or LL.M. in the related field of the position to be filled (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). The education portion must include courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. Education must have been obtained in an accredited college, or university. NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation.

OR

COMBINING EDUCATION AND EXPERIENCE (Transcript Required) - Combinations of successfully completed graduate level education (beyond a master's degree) and specialized experience as described above to meet total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). NOTE: Copies of transcripts must be submitted with your application materials. Education cannot be credited without documentation.

NOTE: One (1) 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.

NOTE: One (1) year of full-time graduate education is considered to be 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 will be considered an academic year of graduate study. Part-time graduate education is creditable in accordance with its relationship to a year of full-time study at the school attended.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Applicants will be referred in the order in which they were received.

Documents Accepted:

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (Schedule A)
• Disability Letter (VA)
• License
• Other (1)
• PCS Orders
• Performance Appraisal
• Professional Certification
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

Documents Required:

• Resume

Please review the above list(s) to ensure you have included all necessary documents required for your application.Not every applicant will require the same documents, therefore it is the applicants responsibility to ensure that their application package includes all necessary documents to determine qualifications and eligibility for appointment, such as a copy of your SF-50, transcript, ICTAP/CTAP documentation (for displaced Federal employees).You will not be contacted for additional information. Applicants will be deemed ineligible if supporting documentation is not submitted.

Veterans' Preference: Since the Direct-Hire Recruitment Authority is being used, traditional Veterans' Preference rules do not apply. Qualified veterans will, however, be given full consideration for this position.

Applications are accepted online. Applying online will allow you to review and track the status of your application.

Next steps