Program Specialist - Human Research Protection Program Coordinator

Full Job Description

This position is aligned within the Research and Development service located at the Veterans Healthcare System in San Francisco, CA.

The primary function of this position is to oversee, review, process and track applications to completion for all human subjects studies performed at the San Francisco VA Medical Center.

The Program Specialist coordinates multiple complex projects and responds to multiple competing demands for resources.

SELECTIVE PLACEMENT FACTOR: A Selective Placement Factor (SPF) has been identified for this position.

Selective Placement Factors (SPF) are a prerequisite to appointment and represent minimum requirements for the position.

Applicants who do not meet the Selective Placement Factor (SPF) are ineligible for further consideration.

The Selective Placement Factor (SPF) for this position is: Experience in a hospital/healthcare setting analyzing initial institutional review board (IRB) applications, modifications, adverse events, renewals or other relevant documents assuring regulatory compliance related to human subject research, including consenting and counseling study participants/patients, conducting chart reviews and reporting of scientific data collection involving human subjects (medical and/or psychological).

In addition to the Selective Placement Factor (SPF), applicant(s) must possess qualifications described below for the grade level(s).

GS-11 SPECIALIZED EXPERIENCE: Requires one full year of specialized experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.

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: coordinating and attending Human Research Protection Program (HRPP) clinical research committee meetings, including setting agendas, recording minutes, and ensuring that changes or additional information required before committee review or final approval are communicated to study teams; using Microsoft Office Suite (Word, Excel, Access) to create documents, spreadsheets, databases and for electronic mail correspondence.

Note: Applicants wishing to receive credit for such experience must clearly indicate the nature of their duties and responsibilities in each position and must include job title, duties, month and year start/end dates AND hour worked per week.

-OR- GS-11 SUBSTITUTION OF EDUCATION FOR EXPERIENCE (TRANSCRIPT REQUIRED): Successfully completed a Ph.D.

or equivalent doctoral degree or 3 full years of progressively higher-level graduate education leading to such a degree or LL.M., if related.

Such education must demonstrate the knowledge, skills, and abilities necessary to do the work.

-OR- GS-11 COMBINATION OF EDUCATION AND EXPERIENCE (TRANSCRIPT REQUIRED): Equivalent combinations of successfully completed graduate education in excess of 2 years and specialized experience may be used to meet total qualification requirements.

GS-12 SPECIALIZED EXPERIENCE: Requires one full year of specialized experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.

To be creditable, specialized experience must have been equivalent to at least the next lower grade level (GS-11) in the normal line of progression for the occupation in the organization.

In addition to the specialized experience for the lower grade above, additional specialized experience for this grade includes: reviewing, analyzing, and corresponding with study teams in corrective actions regarding Human Research Protection Program (HRPP) protocol violations and other reportable events through initial institutional review board (IRB) reporting systems; makes recommendations offering Human Research Protection Program (HRPP) privacy and protocol improvement suggestions.

Note: Applicants wishing to receive credit for such experience must clearly indicate the nature of their duties and responsibilities in each position and must include job title, duties, month and year start/end dates AND hour worked per week.

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/.

PHYSICAL REQUIREMENTS: The work is sedentary. Typically, the employ may sit comfortably to perform all portions of the work.

However, there is periodic walking, standing, bending, carrying light items such as medical records, instructional materials, books, and manuals. No special physical demands are required. 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*** This position involves a multi-grade career ladder.

The major duties listed below represent the full performance level of GS-12. At the GS-11 level, you will perform assignments of a more limited scope and with less independence.

You will progressively acquire the background necessary to perform at the full performance level of GS-12.

Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds.

Duties will include but may not be limited to the following: Oversees, reviews, and processes applications to completion for all human subject research (HSR) studies.

Analyzes submissions (initial applications, modifications, correspondence, renewals, other relevant documents) for conformance with regulations, statue statutes, policies and procedures regarding human subject research (HSR), data privacy (HIPAA), and conflict of interest.

Maintains records according to applicable regulatory requirements.

Provides advice on and answers questions about administrative and technical matters where the guidance/regulations are unclear or non-existent regarding the applications (no scientific review required) from Principal Investigators (PIs) and clinical research staff.

Attends initial institutional review board (IRB) and Research Committee meetings, setting agendas, recording minutes, and ensuring that changes or additional information required before committee review or final approval are communicate to study teams.

Recommends changes in staffing and procedures where necessary to conform to federal and state laws, regulations, and guidance of applicable federal agencies.

Reviews, analyzes, and corresponds with study teams in corrective actions regarding Human Research Protection Program (HRPP) protocol violations and other reportable events through initial institutional review board (IRB) reporting systems.

Utilizes Microsoft Office Suite (Word, Excel, Power Point, Access, etc.) to create documents, spreadsheets, databases and for electronic mail correspondence. Performs other duties as necessary.

Work Schedule: Full time, Monday - Friday 8:00 am - 4:30 pm Recruitment & Relocation Incentives: Not authorized Critical Skills Incentive (CSI): Not Approved