Duties
Duties and responsibilities include but are not limited to:
IRB, Central IRBs, and/or HRPP Program Administration
- Oversees and manages these programs and their activities, including preparation of committee and reviewer materials with appropriate documentation, ensuring projects are reviewed by appropriate personnel, and ensuring all outstanding issues related to project management are resolved in a timely manner.
- Serves in an advisory capacity to the R&D Leadership, research investigators, research committee members, and research committee Chairs and others on issues relative to carrying out the institution's research activities involving the use of humans for investigative purposes.
- Serves as the accreditation Facility Liaison.
- Oversees the protocol review process of multiple programs and committees, ensuring projects are reviewed by appropriate personnel, including the Information Systems Security Officer (ISSO) and Privacy Officer (PO), and issues related to project management are resolved.
- Develops and maintains a pre-review program that will coincide with the Minneapolis VA Health Care System IRB and Central IRBs, and/or R&D Committee, review of all research involving human subjects and the human research protection program.
- Develops and manages required annual and semi-annual reviews of the assigned programs.
- Stays informed on guidelines relating to security and safety in the conduct of research and advises Research and Safety leadership, as needed.
- Educates the investigative community of local and external policies and procedures with regards to research involving human subjects.
- Develops reporting procedures, sampling techniques, and measurements at various points in the research committee process and research programs to identify problem areas or inherent weaknesses in work processes, procedures, information systems and content.
Quality and Compliance
- Responsible for maintaining the federal-wide assurance with the Office of Human Research Protection and ensuring IRBs are appropriately constituted and registered.
- Analyzes and evaluates each research project to ensure compliance with Federal and State regulations, including but not limited to VA, FDA, OHRP (Office of Human Research Protection), VA Office of Research Oversight (ORO), and other applicable regulatory and procedural requirements.
- Develops programs, policies, and procedures within the Research Service.
- Monitors quality assurance program implementation and indicators designed to prevent erroneous transactions and ineffective work practices and to verify adherence to quality assurance plans and requirements.
- Responsible for alerting investigators of deficiencies found within their submissions and educating them as to the steps required to correct the deficiencies.
Administrative Oversight
- Assumes responsibility in preparing for all external reviews.
- Researches and/or analyzes problems, administrative issues, or program requirements as they relate to human subjects or research and the research review process.
- Initiates or reviews correspondence for all research.
- Oversees and refines customized, networked computerized databases to allow for timely tracking of research projects.
- Serves as the electronic records system administrator for the Research Office.
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
Position Description Title/PD#: Health System Specialist - Research Committee Manager/PD99493S and PD99586
Physical Requirements: The work is primarily sedentary, although some slight physical effort may be required. Work is typically performed in an adequately lighted and climate-controlled office. May require occasional travel.
Relocation/Recruitment Incentives: Not Authorized
Critical Skills Incentive (CSI): Not Approved
Permanent Change of Station (PCS): Not Authorized
Financial Disclosure: Not Required
Requirements
Conditions of Employment
- You must be a U.S. citizen to apply for this job
- Subject to a background/suitability investigation
- May serve a probationary period
- Selective Service Registration is required for males born after 12/31/1959
- A complete application package; Resume, Transcripts, etc.
- Selected applicants will be required to complete an online onboarding process
Qualifications
To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 03/07/2025.
To qualify for this position at the GS-09 level, you must meet one of the following:
- Specialized Experience: One year of specialized experience (equivalent to the GS-07 grade level in the federal service); experience that equipped the applicant with the particular knowledge, skills and abilities (KSA's) and other characteristics to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled, in the normal line of progression for the occupation in the organization. Specialized experience includes: perform qualitative and quantitative analytical techniques such as: data analysis, literature search, determining staff to workload ratios, development and administration of questionnaires, graphing, and calculation of means, modes, standard deviations, or similar statistical measures; conduct interviews with supervisors and employees to obtain information about organizational missions, functions, and work procedures; perform a variety of complex tasks related to the approval and maintenance of research projects including regulatory approvals, submissions that are tied to protocol execution, preparation of reports based on a statement of the issue or problem, observations and recommendations for action findings; and possess the ability to use Microsoft Word, Outlook, Excel, PowerPoint, Adobe Pro for word processing, communications, presentations, data manipulation and data storage. OR
- Education (Transcript Required): To qualify based on education for this grade level you must have a master's or equivalent graduate degree or two (2) full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related with a major study in hospital admin, public health admin, or related fields such as business or public admin with course work in health care admin. Education at the graduate level must demonstrate the knowledge, skills, and abilities necessary to do the work. OR
- Combination (Transcript Required): Your total qualifying experience and total qualifying education are each figured as a percentage of the experience and education required for the GS-09 level of the occupation being filled and the total of the two percentages must equal 100 percent to qualify. Only graduate education in excess of 1 year may be used to qualify applicants for positions at the GS-09.To calculate, first identify the percentage of required education you have earned (when substituting, you cannot use the first 60 semester hours that you earned). Then identify the percentage of required experience you possess. Add the two percentages. The total percentage must equal at least 100 percent to qualify at the GS-09. For example, an applicant who has 9 semester hours of graduate level education (i.e. 50% of graduate education required) and 6 months of creditable specialized experience (i.e. 50% of the required experience) would equal 100% of the required experience for the position.
To qualify for this position at the GS-11 level, you must meet one of the following:
- Specialized Experience: You must possess at least one (1) full year of specialized experience that equipped you with the knowledge, skills, and abilities to successfully perform the duties of a Health System Specialist - Research Committee Manager and provided you with knowledge of the full scope of activities required to conduct single and multisite research in the areas of human subjects protection and Institutional Review Boards (IRB) through regulatory and policy compliance. 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 progressively responsible analytical or administrative, or clinical management or supervisory experience in the health care field. This work may have been performed in an operating health care facility or a higher organizational echelon with advisory or directional authority over such facilities. Work must have involved a close working relationship with facility managers and analysis and/or coordination of administrative, clinical, or other service activities, and provided knowledge of the following: (a) Missions, organizations, programs, and requirements of health care delivery systems; (b) Regulations and standards of various regulatory and credentialing groups; (c) Government-wide, agency, and facility systems and requirements in various administrative areas such as budget, personnel and procurement; and knowledge of cognitive engineering, human factors engineering, human-computer interaction, or related fields. OR
- Education (Transcript Required): Successfully completed a Ph.D. or equivalent doctoral degree, three (3) full years of progressively higher level graduate education leading to such a degree, or LL.M. in the related field of the position to be filled (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration). The education portion must include courses that demonstrate the knowledge, skills, and abilities necessary to do the work of this position. Education must have been obtained in an accredited college, or university. OR
- Combination (Transcript Required): Combinations of successfully completed graduate level education (beyond a master's degree) and specialized experience as described above to meet total experience requirements. The education portion must include graduate courses that demonstrate the knowledge, skills, and abilities necessary to do to the work of this position (i.e., hospital administration, public health administration, or related fields such as business or public administration with course work in health care administration).
You will be rated on the following Competencies for this position:
- Administration and Management
- Critical Thinking
- Project Management
- Research
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.
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.
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
A transcript must be submitted with your application if you are basing all or part of your qualifications on education.
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.
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
Documents Accepted:
- Cover Letter
- DD-214/ Statement of Service
- Disability Letter (VA)
- Resume
- Separation Notice (RIF)
- SF-15
- SF-50/ Notification of Personnel Action
- Transcript
Documents Required:
Please review the above list(s) to ensure you have included all necessary documents required for your application. Not every applicant will require the same documents, therefore it is the applicants responsibility to ensure that their application package includes all necessary documents to determine qualifications and eligibility for appointment, such as a copy of your SF-50, transcript, ICTAP/CTAP documentation (for displaced Federal employees).
You will not be contacted for additional information. Applicants will be deemed ineligible if supporting documentation is not submitted.
Veterans' Preference: Since the Direct-Hire Recruitment Authority is being used, traditional Veterans' Preference rules do not apply. Qualified veterans will, however, be given full consideration for this position.
Applications are accepted online. Applying online will allow you to review and track the status of your application.
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 occupational questionnaire and submit the documentation specified in the Required Documents section. The complete application package must be submitted by 11:59 PM (EST) on 03/07/2025 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12702955.
1. To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
2. 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 Details 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 USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
NOTE: Participation in the seasonal influenza program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). It is a requirement that all HCP to receive annual seasonal influenza vaccination or obtain an exemption for medical or religious reasons. Wearing a face mask is required when an exemption to the influenza vaccination has been granted. HCP in violation of this directive may face disciplinary action up to and including removal from federal service. HCP are individuals who, during the influenza season, work in VHA locations or who come into contact with VA patients or other HCP as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased medical facilities. HCP include all VA licensed and unlicensed, clinical and administrative, remote and onsite, paid and without compensation, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, researchers, volunteers and health professions trainees (HPTs) who are expected to perform any or all of their work at these facilities. HPTs may be paid or unpaid and include residents, interns, fellows and students. HCP also includes VHA personnel providing home-based care to Veterans and drivers and other personnel whose duties put them in contact with patients outside VA medical facilities.
Next steps
After the vacancy announcement closes, applicants are evaluated to ensure qualification and eligibility requirements are met. After the review is complete, a referral certificate(s) is issued and applicants will be notified of their status by email.