Clarification from the agency

Open to current, permanent employees of the Veterans Health Administration including Title 38, Hybrid Title 38, and VCS employees covered by VA/OPM Interchange Agreements and those eligible under CTAP. This does not include temporary, term, or intermittent appointments.

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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.

Conditions of employment

• You must be a U.S. Citizen to apply for this job
• Selective Service Registration is required for males born after 12/31/1959
• Subject to background/security investigation
• 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 dentification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.
• Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)

• 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, 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/.

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.

Narrative responses are not required at this time. If you are referred for consideration, you may be asked to submit additional job related information, which may include, but not limited to; responses to the knowledge, skills and abilities; completion of a work sample, and/or contact for an interview. Your resume and/or supporting documentation will be verified. Please follow all instructions carefully. Errors or omissions may affect your rating or consideration for employment.

The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.

For more information on the "Who may apply" eligibility requirements, please refer to the OHRM Status Candidates and Other Candidate Definitions document.

Placement Policy: The posting of this announcement does not obligate management to fill a vacancy or vacancies by promotion. The position may be filled by reassignment, change to lower grade, transfer, appointment, or reinstatement. Management may use any one or any combination of these methods to fill the position.

It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.

Veterans and Transitioning Service Members: Please visit the VA for Vets site for career-search tools for Veterans seeking employment at VA, career development services for our existing Veterans, and coaching and reintegration support for military service members.