Program Specialist

Full Job Description

This position is located at the West Haven Cooperative Studies Program Coordinating Center (CSPCC) at the VA Connecticut Healthcare System.

The Cooperative Studies Program (CSP) is a national clinical trials program providing collaboration for research design, statistical analysis, data management, regulatory, technical, education, and administrative coordination.

This is a developmental GS-09 level position, full performance-level is GS-11. To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 03/30/2026.

Time-In-Grade Requirement: Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement.

For a GS-09 position you must have served 52 weeks at the GS-07. The grade may have been in any occupation, but must have been held in the Federal service.

An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials.

If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement.

In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade.

You may qualify based on your experience and/or education as described below: Specialized Experience GS-09: You must have one year of specialized experience equivalent to at least the next lower grade GS-07 in the normal line of progression for the occupation in the organization.

Examples of specialized experience would typically include, but are not limited to: Administrative knowledge of a wide range of concepts, principles, and practices in the scientific area to support the organization's health science clinical trials program; developing successful study protocols for the clinical trial proposals; management of approved CSP multi-center clinical trials; perform complex analytical studies and interpretation of results to coordinate the evaluation of medical/scientific programs and policies and to recommend improvements; liaison for numerous aspects of the CSP clinical trial(s); high level interpersonal skills and good judgment in working within a medical setting; communicate, both orally and in writing to make presentations, explain recommendations, provide guidance and advise program administrators; respond to inquiries, and prepare reports..

OR, Education: Applicants may substitute education for the required experience.

To qualify based on education for this grade level you must have completed a master's degree or equivalent graduate degree OR 2 full years of progressively higher level graduate education leading to such a degree OR LL.B.

or J.D., if related. OR, Combination: Applicants may also combine education and experience to qualify at this level.

You must have an combination of specialized experience and education beyond beyond one full year of graduate education. NOTE: Transcripts must be submitted with your application package.

Specialized Experience GS-11: You must have one year of specialized experience equivalent to at least the next lower grade GS-09 in the normal line of progression for the occupation in the organization.

Examples of specialized experience would typically include, but are not limited to: Advance Administrative knowledge of a wide range of concepts, principles, and practices in the scientific area to support the organization's health science clinical trials program; developing successful study protocols for the clinical trial proposals; management of approved CSP multi-center clinical trials; perform complex analytical studies and interpretation of results to coordinate the evaluation of medical/scientific programs and policies and to recommend improvements; liaison for numerous aspects of the CSP clinical trial(s); high level interpersonal skills and good judgment in working within a medical setting; communicate, both orally and in writing to make presentations, explain recommendations, provide guidance and advise program administrators; respond to inquiries, and prepare reports..

OR, Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have completed 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 OR, Combination: Applicants may also combine education and experience to qualify at this level.

You must have an combination of specialized experience and education beyond beyond a masters degree. NOTE: Transcripts must be submitted with your application package.

You will be rated on the following Competencies for this position: Project Management Self Management Oral Communication Written Communication Interpersonal Skills Teamwork 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; religions; 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. Note: A 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.

Physical Requirements: The work is mostly sedentary with some walking, standing, bending, carrying of light items such as instructional material, book and manuals.

A degree of manual dexterity is required to use computers and office equipment.

The job at times can be demanding and stressful because deadlines have to be met, cooperation has to be obtained from people, unavoidable delays are encountered, information is often lacking, and key people cannot be contacted when needed.

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:

Major Duties Manages all administrative aspects of a trial/study, while acting as the primary interface between the sponsor and investigative institutions (sites).

Provides advice to study sites and study chair relating to VA and FDA requirements. Communicates regularly and leads conference calls with the Executive Committee regarding clinical trial issues.

Manages the trial budget and makes decisions related to the financial management of the study/clinical trial.

Provides administrative scientific and technical support to programs, projects, or studies based on project evaluations, knowledge of related guidelines, research coordination projects, and new developments in the field.

Conducts Risk Based Monitoring activities associated with identifying and analyzing risks, developing appropriate responses and monitoring risk triggers.

Ensures all study personnel are trained in administrative aspects of the clinical trial, including regulatory requirements and patient safety reporting.

Ensures that CSP and study sites are complying with VA and FDA clinical trials regulations Communicates with the Pharmaceutical company regarding the management of the trial and budget issues.

Communicates with the local participating sites' Research & Development Office to obtain and answer queries relating to study administrative, financial and regulatory items.

Monitors the expenditures of study funds and FTEE to ensure that the study is within budget.

Monitors and ensures regulatory adherence of sites and collects and maintains appropriate documentation for sponsor site files.

Consults with government regulatory agencies (FDA OHRP, v_ A Office of Research Oversight) for guidance on specific issues of patient safety, confidentiality, participant rights, and trial management that arise during the trial.

and guidance. Promotion Potential: The selectee may be promoted to the full performance level without further competition when all regulatory, qualification, and performance requirements are met.

Selection at a lower grade level does not guarantee promotion to the full performance level. Work Schedule: Monday - Friday, 8:00am - 4:30pm Compressed/Flexible: Not Authorized.

Telework: Ad Hoc Position Description/PD#: Program Specialist/PD00309A and PD00310A Relocation/Recruitment Incentives: Not Authorized. Critical Skills Incentive (CSI): Not Approved.

Permanent Change of Station (PCS): Not Authorized.