Program Specialist

Full Job Description

The purpose of this position is to serve as the Human Research Protection Program (HRPP) Coordinator at the Birmingham VA Health Care System (BVHCS).

For GS-11: Possess at least one (1) year of specialized experience that equipped you 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 of GS-9 in Federal service.

Specialized experience is possessing of medical research information to properly review research proposals, verify adherence to human subject protection regulations and policies to evaluate actions taken by investigators and compliance with approved research protocols; understanding of the function of the regulatory committees and their respective importance and relevance to medical research including human subjects studies; using of computer software programs equivalent to Microsoft Word, Excel, Access, Outlook, etc.

to generate presentations, briefings, and reports. OR Possess 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.

Education at the graduate level in an accredited college or university to meet the requirements for positions at GS-11.

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

(TRANSCRIPTS REQUIRED) OR Possess a combination of successfully completed post-high school education and experience to meet total qualification requirements for grade level of GS-11.

To be computed by first determining the total qualifying experience as a percentage of the experience required for the grade level; then determining the education as a percentage of the education required for the grade level; and then adding the two percentages.

The total percentages must equal at least 100 percent to qualify for the grade level.

Only graduate education in excess of the amount required for the next lower grade level may be used to qualify for positions at GS-11.

(TRANSCRIPTS REQUIRED) 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*** Major Duties and Responsibilities: Responsible for providing guidance to Medical Center leadership, the Institutional Review Board (IRB), clinical staff, research scientists and administrators on the interpretation and application of the federal, state and local rules governing the conduct of human studies research.

Provides information to the respective regulatory research committees regarding the ever-changing and evolving regulations and news items pertaining to medical research and human studies.

Reviews all investigator studies for administrative content and completeness as they are received in the Research Service office prior to consideration by the appropriate committee or subcommittee.

Performs full reviews of local investigators' studies as part of the institutional quality assurance procedures.

Drafts memoranda to Investigators and Committee/Subcommittees members relating to required determinations, outlines deficiencies and specifies dates for resubmission.

Evaluates responses from investigators and requests additional information as necessary to address committees' concerns.

Handles communication with the investigators, private research agencies/foundations/nonprofits, other governmental research organizations, commercial research funding sources and industry.

Responsible in preparing and managing the schedule, agendas, and reviewing action items for the IRB Committee/Subcommittees. Performs all duties as assigned.

Work Schedule: M-F (8am - 4:30pm) Recruitment & Relocation Incentives: Not authorized Telework: This position may be authorized for telework.

Telework eligibility will be discussed during the interview process.