The Program Analyst - Research has primary administrative oversight and responsibility for the Human Research Protection Program to safeguard the rights and welfare of human research subjects.
Duties includes, but may not be limited to the following:
Advises, informs and instructs research investigators and research team personnel on proper submissions of the protocol, optimum submission strategies, and assures compliance with Federal regulations, Institutional Review Board (IRB) and other applicable requirements.
Oversees the research compliance mail in-box, processes new transactions, follow-up on research issues, archives and tracks transactions and regulatory documents.
Educates investigators and coordinators on research and IRB submission applications.
Organizes and tracks multiple simultaneous research projects, multiple committees and reviewers. Provides administrative support to direct, interact, collect and process documents for up to 5 subcommittee reviews and up to 6 other individual pre-reviews on research projects.
Creates annual calendars, monthly agendas and prepares submission documents for each committee/sub-committee. Agendas include attention to detail on human research transactions (amendments, reviews, close-out, items of adverse events, non-compliance in the performance of research).
Reviews IRB and Research submissions and communicates deficiencies found to investigators.
Prepares letters describing the official conclusions of meeting deliberations. Communicates unapproved research, communicates directly with the MD/PhD research investigator, refer to them to Research Compliance (RC) Officer/RC Nurse, and follow up until issues are resolved. Serves as liaison between reviewers and investigators.
Maintains knowledge of policies, handbooks, and other requirements for research. This will involve participating in conference calls; interpreting policy, guidance and directives; attending meetings, contacting national-level content experts for clarification.
Serve as program manager for the up-keep of databases designed by research, supporting 300 or more research projects, which manages research projects, initial and annual progress reports, and annual renewal of human studies. Manages the research study databases, used to monitor/track research activity. Responsible for the integrity, accuracy, current data of the databases.
Coordinates and prepares for inspection team(s) visits and facilitates the teams' review of documents, investigators, and internal and external affiliated members.
Performs other duties as necessary
Work Schedule: Monday-Friday, 8:00am - 4:30pm Recruitment & Relocation Incentives: Not authorized Financial Disclosure Report: Not Required
Designated and/or random drug testing may be required
Selective Service Registration is required for males born after 12/31/1959
May be required to serve a probationary period
Selected applicants will be required to complete an online onboarding process
Qualifications
TO QUALIFY FOR THE PROGRAM ANALYST - RESEARCH GS-343-9 YOU MUST MEET ONE OF THE FOLLOWING:
SPECIALIZED EXPERIENCE: Requires one year of specialized experience equivalent to at least GS-7 grade level in the Federal service 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. Specialized experience includes working in a clinical or academic research setting tracking numerous, simultaneous research projects; preparing and submitting human subjects research projects to Institutional Review Boards (IRB); instructing research investigators and study personnel on research regulatory requirements (i.e., IRB, Food and Drug Administration (FDA), Human Research Protection (HRP) on proper submissions through required committees; managing multiple research databases; and creating research submissions calendar, preparing agendas and meeting minutes. (Resume(s) must clearly support the required experience to receive credit. We will not make assumptions regarding experience) -OR- SUBSTITUTION OF EDUCATION FOR EXPERIENCE (TRANSCRIPT REQUIRED): Successfully completed a master's 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 OF EDUCATION AND EXPERIENCE (TRANSCRIPT REQUIRED): Combinations of successfully completed graduate education and specialized experience, as described above, may be used to meet total qualification requirements. Only graduate education in excess of One year (excess of 18 semester hours) is creditable towards this requirement.
You will be rated on the following Competencies as part of the assessment questionnaire for this position:
Analysis and Problem Solving
Analytical Reasoning
Quality Management
Technical Competence
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.
IMPORTANT: 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. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html.
Additional information
Physical Requirements: Work is primarily sedentary, although some slight physical effort may be required.
Receiving Service Credit for Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. VA may offer newly-appointed Federal employee's credit for their job-related non-federal experience or active duty uniformed military service. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.
Special Employment Consideration: VA encourages persons with disabilities to apply, including those eligible for hiring under 5 CFR 213.3102(u), Schedule A, Appointment of persons with disabilities (i.e., intellectual disabilities, severe physical disabilities, or psychiatric disabilities), and/or disabled veterans with a compensable service-connected disability of 30% or more. For more information on how to apply using this appointment authority via the Selective Placement Coordinator within the office, contact the facility Human Resources Department at (716) 834-9200.
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.
The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation and be found well-qualified (have a final rating of 85 or more before any Veterans preference points) for this vacancy. Information about ICTAP and CTAP eligibility is on OPM's Career Transition Resources website at http://www.opm.gov/policy-data-oversight/workforce-restructuring/employee-guide-to-career-transition/.
This job opportunity announcement may be used to fill additional vacancies.
If you are unable to apply online view the following link for information regarding an Alternate Application.
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.
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.
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.
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).
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.
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.
IMPORTANT: Please ensure your resume include up-to-date contact information (phone number(s), email address(s), etc.)
To apply for this position, you must provide a complete Application Package which includes:
Resume
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)
OF-306
Other (1)
Other (2)
Resume
Separation Notice (RIF)
SF-15
SF-50/ Notification of Personnel Action
Transcript
Veterans' Preference: When applying for Federal Jobs, eligible Veterans should claim preference for 5pt (TP), 10pt (CP/CPS/XP), or for Sole Survivor Preference (SSP) in the questionnaire. You must provide a legible copy of your DD214(s) which shows dates and character of service (honorable, general, etc.). If you are currently serving on active duty and expect to be released or discharged within 120 days you must submit documentation related to your active duty service which reflects the dates of service, character of service (honorable, general, etc.), and dates of impending separation. Additionally, disabled veterans and others eligible for 10-point preference (such as widows or mothers of eligible Veterans) must also submit an SF-15 "Application for 10 Point Veteran Preference" with required proof as stated on the form. Documentation is required to award preference. For more information on Veterans' Preference, please visit http://www.fedshirevets.gov/job/vetpref/index.aspx.
If you are relying on your education to meet qualification requirements:
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.
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 07/24/2019 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/10554221.
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.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). HCP are individuals who, during the influenza season, work in VHA locations where patients receive care or who come into contact with VA patients 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 facilities. HCP include all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work at these facilities. HCPs that are unable to receive or otherwise decline a flu shot will be expected to wear a face mask throughout the influenza season.
VA Western New York Healthcare System
3495 Bailey Avenue
Buffalo, NY 14215
US
Next steps
Once your online application is submitted you will receive a confirmation notification by email. After the vacancy announcement closes, we will review applications per Category Rating procedures 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. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
IMPORTANT: Please ensure your resume include up-to-date contact information (phone number(s), email address(s), etc.)
To apply for this position, you must provide a complete Application Package which includes:
Resume
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)
OF-306
Other (1)
Other (2)
Resume
Separation Notice (RIF)
SF-15
SF-50/ Notification of Personnel Action
Transcript
Veterans' Preference: When applying for Federal Jobs, eligible Veterans should claim preference for 5pt (TP), 10pt (CP/CPS/XP), or for Sole Survivor Preference (SSP) in the questionnaire. You must provide a legible copy of your DD214(s) which shows dates and character of service (honorable, general, etc.). If you are currently serving on active duty and expect to be released or discharged within 120 days you must submit documentation related to your active duty service which reflects the dates of service, character of service (honorable, general, etc.), and dates of impending separation. Additionally, disabled veterans and others eligible for 10-point preference (such as widows or mothers of eligible Veterans) must also submit an SF-15 "Application for 10 Point Veteran Preference" with required proof as stated on the form. Documentation is required to award preference. For more information on Veterans' Preference, please visit http://www.fedshirevets.gov/job/vetpref/index.aspx.
If you are relying on your education to meet qualification requirements:
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.
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 07/24/2019 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/10554221.
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.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). HCP are individuals who, during the influenza season, work in VHA locations where patients receive care or who come into contact with VA patients 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 facilities. HCP include all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work at these facilities. HCPs that are unable to receive or otherwise decline a flu shot will be expected to wear a face mask throughout the influenza season.
VA Western New York Healthcare System
3495 Bailey Avenue
Buffalo, NY 14215
US
Next steps
Once your online application is submitted you will receive a confirmation notification by email. After the vacancy announcement closes, we will review applications per Category Rating procedures 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. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
