Duties

Summary

This position is one of Program Specialist - Research Coordinator, with the Research and Development Service (R&D), Salem VA Medical Center, Salem, Virginia. The Program Specialist - Research Coordinator will support R&D, which aims to create resources within VA that would allow researchers to conduct clinical research studies. Registered Nurses are preferred.

Note: This is a term appointment not to exceed 4 years

Learn more about this agency

Responsibilities

The Program Specialist - Research Coordinator, reporting to the Principal investigator(s), will be responsible for overseeing and organizing the day-to-day operations of clinical research studies, including enrolling participants, collecting data, and serving as a critical conduit to the Salem VA Human Research Protection Program (IRB and Research and Development Committees). The Program Specialist - Research Coordinator will manage the clinical and administrative support services for clinical research studies and will directly supervise the Research Assistant and other research staff assigned to the research study.
Major duties include:

Clinical Research Studies Management

Manage and oversee day-to-day activities of clinical research studies, including all actions related to overseeing clinical research studies personnel, enrolling and consenting patients, the proper collection of data, and maintaining records. Ensure proper collection and shipment of blood specimens, per clinical research studies protocol, by local site Research Assistants. Responsible for reviewing documentation completed by clinical research studies personnel for accuracy and completeness of all local site documentation and records in the Investigator Study File. The Investigator Study File consists of all records and materials pertaining to clinical research studies, including participant files and related correspondence and regulatory documents.

Serve as primary point of contact at the site for clinical research studies with service providers; such as facilities, HR, IT, Fiscal Office, ISO, and Office of Communications. On behalf of the LSI, actively manage and coordinate all submissions to the VA Central IRB and local R&D Committee. Ensure timely and complete submission of VA Central IRB documentation to Coordinating Centers as requested. Prepare and submit all necessary documentation to local R&D. Responsible for escalating issues/concerns to all relevant stakeholders including adverse participant safety events, and other necessary communications.

Prepare reports and any requested VA progress reports for VA Central IRB and Office of Research and Development staff. Develop and give presentations on research study performance and results to local site staff and ORD staff as requested. Collaborate with Coordinating Center staff to develop and implement public relations strategies. Liaise with the local Office of Communications to manage PR activities and initiatives through VACO. Actively engage in initiatives generated by site and VACO. Responsible for ensuring clinical research studies maintains compliance with all applicable regulatory concerns, including human subject protection and information security. Regularly review any changes to clinical research studies protocol and operations manual to maintain regulatory compliance.

Responsible for all quality assurance activities related to clinical research studies and for correcting any deviations from QA standards.

Utilize effective practices for attracting and retaining clinical research studies personnel including research assistants. Work with HR as appropriate to participate in selection, performance management and address employee relations issues in line with VA guidelines. Oversee and supervise the activities of other clinical research studies personnel, including research assistants. Ensure clinical research studies personnel follow all applicable protocols and regulations, including requirements for the protection of human subjects and research safety and security. Provide guidance to clinical research studies personnel in unique situations and authorize deviations from protocol as appropriate.

Recruitment & Enrollment

Serve as local site point of contact for all activities related to enrollment, including special events, and participant visits. Develops and participates in public relations activities. Develops plans for expanding recruitment efforts within IRB guidelines and clinical research studies protocol, including working with local site communication office in Veteran outreach programs.

Oversee enrollment of clinical research studies participants and obtain informed consent and HIPAA authorization. Ensures all enrollment activities conducted by clinical research studies personnel are in compliance with all regulations and clinical research studies protocol. Enrollment will include a discussion of the consent process including an overview of the research program and its risks and benefits. The incumbent must have a thorough understanding of all aspects of consent in order to appropriately address any patient questions.

Performs other directly related duties as assigned.

Work Schedule: Monday - Friday, 8am - 4:30pm
Position Description/PD#: Program Specialist/PD02013A
Relocation/Recruitment Incentives: Not authorized
Financial Disclosure Report: Not required

Travel Required

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

Supervisory status
No

Promotion Potential
None

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, 04/07/2020.

Must have a master's degree or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree OR at least one year of specialized experience at the next lower grade (GS-7).

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-9 position you must have served 52 weeks at the GS-7 . 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 will be rated on the following Competencies for this position:

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.

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

Receiving Service Credit or 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. Contact the Agency Contact for information on how to apply under this appointment authority via the Selective Placement Coordinator.

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
Suitability/Fitness

Required Documents

To apply for this position, you must provide a complete Application Package which includes:

• Resume

Please read the below paragraph carefully. Other forms are required to be submitted.

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.

• 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.