Program Support Assistant (Term NTE 2 Years)

Employer
USAJobs
Location
Perry Point, Maryland
Posted
Sep 10, 2020
Closes
Sep 18, 2020
Hours
Full Time
Duties

Summary

This position is located in the Cooperative Studies Program Coordinating Center (CSPCC), Office
of Research and Development (ORD) at the VA Maryland Healthcare System (VAMHCS) in Perry
Point, MD. The incumbent provides administrative support to Project Managers to facilitate
the progress of clinical research trials from its inception to completion. The Program Support
Assistant serves under the direct supervision of the Administrative Officer.
Learn more about this agency

Responsibilities

The incumbent will be working as a Program Support Assistant and performing the following duties:
  • Assist the trial project managers to request and track annual Institutional Review Board (IRB)and Research and Development (R&D) approval status for participating medical centers to ensure regulatory compliance for all active trials assigned to the center.
  • Assist the trial project managers and the program specialist, regulatory affairs in reviewing
    Informed Consent forms (ICFs) for completeness and accuracy throughout the course of the
    actively recruiting trials assigned to the center.
  • Assist the trial project manager, the auditing specialist and the program specialist, regulatory
    affairs in performing audits of all site regulatory documents to ensure completeness and
    compliance with Good Clinical Practice (GCP), CSP and VA regulatory requirements.
  • Work in collaboration with the trial project managers to track trainings for all participating
    medical centers' personnel to ensure compliance with regulatory requirements.
  • Work in collaboration with the trial project managers to update trial SharePoint sites with study documents, personnel lists, training dates, lab certifications, and other pertinent information as required by the trials during the active phases of the assigned trials.
  • Assist the trial project managers to maintain and monitor Central Study Files for assigned trials according to file designations and naming conventions.
  • Work in collaboration with the trial project managers and the associate center director for
    operations to collect, organize, and select from multiple resources in to order to develop more efficient processing procedures such as developing a center-wide standardized method for identifying and retrieving electronic or hard copy stored information; prepare study records for storage and archival; document accurate inventory of study records storage location for trials conducted at the center.
  • Assist the trial project managers to update trial-related databases and Annual Report related to study status, meetings, study personnel, and publications.
  • Serve as a center representative on one or more program or center committee.
  • Actively participates in Quality Assurance activities to include: provide services that meet
    customer requirements, ensure continuous improvement, ensure conformance to regulatory
    requirements, participate in internal and annual audits, identify internal process inefficiencies
    and provide solutions.
  • Assist the project managers in production and distribution of study documents.
  • Work in collaboration with the project managers, Biostatisticians and the respective Chair's
    Office to prepare study Operations Manual and Study Protocol for all trials assigned to the
    center.
  • Assist the project managers to prepare submissions to the Cooperative Studies Evaluation
    Board, Human Rights Committee (HRC), Institution Review Boards (IRB), Data Monitoring
    Committee (DMC) and other regulatory bodies in accordance with CSPCC guidelines.
  • Assist the meeting organizers to prepare agenda and draft minutes for internal study meetings, and other center-related meetings as needed.
  • Assist the project managers in preparing prototype letters.
  • Other related duties as assigned.
Work Schedule: Monday through Friday, 8:00 am-4:30 pm
Telework: Available
Virtual: This is not a virtual position.
Position Description/PD#: Program Support Assistant (Term NTE 2 Years)/PD512-20021-0
Relocation/Recruitment Incentives: Not Authorized
Financial Disclosure Report: Not required

This is a TERM Appointment Not To Exceed 2 Years.

Travel Required

Occasional travel - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
5

Requirements

Conditions of Employment

  • You must be a U.S. Citizen to apply for this job
  • Designated and/or random drug testing may be required
  • Selective Service Registration is required for males born after 12/31/1959
  • You may be required to serve a probationary period
  • Subject to background/security investigation
  • 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, 09/18/2020.

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-05 position you must have served 52 weeks at the GS-04. 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.

Note: Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment.

You may qualify based on your experience and/or education as described below:
  • Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-04 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: providing administrative support, communication, proficient in navigating, preparing, and discussing reports, independently relay information, ability to navigate reports, create competency folders, maintain records.
OR,
  • Education: Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have 4 years above high school. This education must have been obtained in an accredited business, secretarial or technical school, junior college, college or university. (TRANSCRIPT REQUIRED).
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 the second year. Only education in excess of the first 60 semester hours (i.e., beyond the second year) is creditable toward meeting the specialized experience requirement. One full academic year of study (30 semester hours) beyond the second year is equivalent to 6 months of specialized experience.
You will be rated on the following Competencies for this position:
  • Clerical
  • Information Management
  • Interpersonal Skills
  • Plan and organize work


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, and carrying of items. However, due to the magnitude and sheer volume of activity, the emotional demands of the position can be high.

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. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html .

Additional information

VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.

The Interagency Career Transition Assistance Plan (ICTAP) and Career Transition Assistance Plan (CTAP) provide eligible displaced Federal/VA competitive service employees with selection priority over other candidates for competitive service vacancies. To be qualified you must submit appropriate documentation (a copy of the agency notice, your most recent performance rating, and your most recent SF-50 noting current position, grade level, and duty location) and be found well-qualified for this vacancy. To be well-qualified : applicants must possess experience that exceeds the minimum qualifications of the position including all selective factors, and who are proficient in most of the required competencies of the job. 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/ .

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.

This job opportunity announcement may be used to fill additional vacancies.

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.

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

If you are unable to apply online view the following link for information regarding an Alternate Application .

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.

Background checks and security clearance

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process

Required Documents

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 make sure you have included other 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 claims, or ICTAP/CTAP documentation (for displaced Federal employees). You will not be contacted for additional information.
  • Cover Letter
  • DD-214/ Statement of Service
  • Disability Letter (Schedule A)
  • Disability Letter (VA)
  • Resume
  • SF-15
  • SF-50/ Notification of Personnel Action
  • Transcript


SF-50, Notification of Personnel Action (if applicable for Time in Grade and/or Eligibility):
  • Most recent SF-50 if you are a current or former Federal employee
  • An SF-50 showing 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
  • Award 50's do not provide sufficient information and will not be accepted for the purpose of verifying time-in-grade.
  • Examples of appropriate SF-50's include:
    • Within grade increases at the highest grade held; or
    • Promotions with an effective date more than one year old; or
    • SF-50's at the highest grade held with an effective date more than one year old.
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:

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.

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