Program Specialist - Clinical Research

at  US Veterans Health Administration

QUALIFICATIONS

SELECTIVE PLACEMENT FACTOR (SCREEN-OUT) - 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 SPF are ineligible for further consideration.
The SPF for this position is: Experience working in a hospital/healthcare administrative research capacity, analyzing human research protection (HRPP) submissions and correspondence for conformance with HRPP regulations and statues for approval and processing.

IN ADDITION TO THE 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: attending HRPP research committee meetings 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. -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 HRPP protocol violations and other reportable events through IRB reporting systems; and makes recommendations offering HRPP privacy and protocol improvement suggestions.

You will be rated on the following Competencies as part of the assessment questionnaire for this position:

• Communications
• Compliance
• Critical Thinking
• Project Management

IMPORTANT: A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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.
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; religious; 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.
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.
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/.

EDUCATION

IMPORTANT: A transcript must be submitted with your application if you are basing all or part of your qualifications on education for the GS-11 grade level.
There is no educational substitution at the GS-12 grade level.
NOTE: Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. You can verify your education here: http://ope.ed.gov/accreditation/. If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education. For further information, visit: Recognition of Foreign Qualifications | International Affairs Office (ed.gov).

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. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
Your responses to the assessment questionnaire will be reviewed along with the information provided in your resume and supporting documentation to determine if you are qualified for the position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your rating may be lowered and/or you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
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.

Candidates who apply under All U.S. Citizens announcements will be rated and ranked using Category Rating procedures. Qualified candidates will be assigned to a quality category. The categories are defined as follows:

• Best qualified - applicants possessing experience that substantially exceeds the minimum qualifications of the position including all selective factors, and who are highly proficient in all requirements of the job and can perform effectively in the position;
• Highly qualified - applicants possessing experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the requirements of the job;
• Well qualified - applicants possessing experience that meets the minimum qualifications of the position including all selective factors, and who are proficient in some, but not all, of the requirements of the job; and
• Qualified - applicants possessing experience and/or education that meets the minimum qualifications of the position including all selective factors.

Application of Veterans’ Preference: Category rating and selection procedures place those with veteran’s preference above non-preference eligibles within each category. Preference eligible applicants that meet the eligibility and qualification requirements and who have a compensable service-connected disability of at least 10 percent are listed in the highest quality category (except when the position being filled is scientific or professional at the GS-09 grade level or higher).
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.

• Benefits

A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

• Required Documents

As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you’re a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you’re eligible under their policies.

IF YOU ARE RELYING ON YOUR EDUCATION TO MEET QUALIFICATION REQUIREMENTS:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

• How to Apply

All applicants are encouraged to apply online. To apply for this position, you must complete the questionnaire and submit the documentation specified in the Required Documents section below. The complete application package must be submitted by 11:59 PM (ET) on 03/22/2024 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12353117.

• To begin, click Apply Online to create a USA JOBS account or log in to your existing account. Follow the prompts to select your USA JOBS resume and/or other supporting documents and complete the occupational questionnaire.
• Click Submit My Answers to submit your application package. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.

To verify your application is complete, log into your USAJobs account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Application page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USA JOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USA JOBS account or your application will be incomplete.

IF YOU ARE RELYING ON YOUR EDUCATION TO MEET QUALIFICATION REQUIREMENTS:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
Help

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, statutes, policies and procedures regarding 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 Research Committee meetings, 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 HRPP protocol violations and other reportable events through IRB reporting systems.
• Utilizes Microsoft Office Suite (Word, Excel, Access) to create documents, spreadsheets, databases and for electronic mail correspondence.
• Performs other duties as necessary

The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please use this checklist to ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50’s (current/former Federal employees), documentation to support Veterans Preference or ICTAP/CTAP documentation (for displaced Federal employees).

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (VA)
• Other (1)
• Other (2)
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcrip

The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please use this checklist to ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50’s (current/former Federal employees), documentation to support Veterans Preference or ICTAP/CTAP documentation (for displaced Federal employees).

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (VA)
• Other (1)
• Other (2)
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcrip