Clarification from the agency

Open to U.S. Citizens, Federal Employee and VA Employees

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The Director must demonstrate an execution of leadership that is categorized as a significant and incessant responsibility and accountability for the safety of patients volunteering to participate in multicentered clinical trials sponsored by the Department of Veterans Affairs (VA), Office of Research and Development {ORD} Cooperative Studies Program (CSP) or cosponsored with other Federal agencies (e.g. NIH, DOD, PHS, etc.) or industry; this leadership significantly influences the VA ORD mission and health care via Good Clinical Practice (GCP) auditing/ monitoring of multicenter clinical trials in the VA ORD CSP.


The Cooperative Studies Program (CSP) is a Program within VHA's Office of Research and Development (ORD). CSP's mission is to advance the health and care of veterans and the nation through cooperative research studies that produce innovative and effective solutions to national healthcare problems. Specializing In very large-scale clinical research studies within the VA, across the United States, and internationally, CSP has conducted many landmark studies and continues to advance the practice of medicine, Including genomic medicine. The CSP currently maintains a diverse portfolio of clinical research studies that seeks to provide definitive answers to important clinical questions on a range of diseases that affect Veterans and the nation.

The Site Monitoring, Auditng and Resources Team (SMART) is the only entity of its type in medical research programs in the federal government and is managed by a Director with highly and specially trained, and experienced GCP monitors and auditors. The mission of SMART is to promote, monitor and audit compliance with GCP and regulatory requirements (VA and FDA) governing clinical trials in the CSP throughout the U.S. Monitoring and auditing of clinical trials assures the rights and safety of patients participating are protected; reported clinical trial data are accurate, complete, and verifiable from source documents; and the conduct of the clinical trial is compliant with the protocol, GCP and applicable FDA and VA regulatory requirements.

The SMART Director manages and directs:

• The national GCP Clinical Quality Control and Assurance Program for CSP,
• Provides support for Program and policy development,
• Directs and supervises Clinical Quality Control and Assurance site inspections (Site and Sponsor),
• Trends site visit findings for CSP quality improvement,
• Directs the GCP training program for VA researchers and CSP site monitors/auditors,
• Oversees the development of tools, worksheets, and GCP guidance for each new CSP clinical trial.

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 a background/security investigation
• Must be proficient in written and spoken English
• Selected applicants will be required to complete an online onboarding process

Qualifications

Applicants pending the completion of educational or certification/licensure requirements may be referred and tentatively selected but may not be hired until all requirements are met.

Pharmacist Basic Requirements:

• United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy.
• English Language Proficiency. Pharmacists must be proficient in spoken and written English as required by 38 U.S.C. 7402(d), and 7407(d).
• Education: Graduate of an Accreditation Council for Pharmacy Education (ACPE) accredited College or School of Pharmacy with a baccalaureate degree in pharmacy (BS Pharmacy) and/or a Doctor of Pharmacy (Pharm.D.) degree. Verification of approved degree programs may be obtained from the Accreditation Council for Pharmacy Education, 20 North Clark Street, Suite 2500, Chicago, Illinois 60602-5109; phone: (312) 664-3575, or through their Web site at: http://www.acpe-accredit.org/. (NOTE: Prior to 2005 ACPE accredited both baccalaureate and Doctor of Pharmacy terminal degree program. Today the sole degree is Doctor of Pharmacy.) (2) Graduates of foreign pharmacy degree programs meet the educational requirement if the graduate is able to provide proof of achieving the Foreign Pharmacy Graduate Examination Commission (FPGEC) Certification, which includes passing the Foreign Pharmacy Graduate Equivalency Examination (FPGEE) and the Test of English as a Foreign Language Internet-Based Test (TOEFL iBT).
• Licensure. Full, current and unrestricted license to practice pharmacy in a State, Territory, Commonwealth of the United States (i.e., Puerto Rico), or the District of Columbia.

• Experience. In addition to the GS-13 requirements, must have 1 year of experience equivalent to the next lower grade level
• Demonstrated Knowledge Skills Abilities. In addition to the experience above, the candidate must demonstrate all of the following KSAs:
  • 1. Skill in persuading others and gaining cooperation to accomplish goals.
  • 2. Ability to effectively communicate orally and in writing regarding complex clinical and technical issues.
  • 3. Skill in utilizing regulatory and quality standards to develop and implement operational programs.
  • 4. Skill in managing multiple and diverse people or programs.
  • 5. Skill in utilizing available resources to support the mission and goals of the organization.

• United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy.
• English Language Proficiency. Psychologist must be proficient in spoken and written English.
• Education: Have a doctoral degree in psychology from a graduate program in psychology accredited by the APA, the PCSAS, or the CPA at the time the program was completed. The specialty area of the degree must be consistent with the assignment for which the applicant is to be employed. For the purpose of meeting this requirement, the term "specialty area" refers to the specific specialty areas recognized by the accrediting body and not to specific job duties that might require special skills. OR Have a doctoral degree in any area of psychology and, in addition, successfully complete a re-specialization program (including documentation of an approved internship completed as part of the re-specialization program) meeting both of the following conditions: (a) the re-specialization program must be completed in an APA or a CPA accredited doctoral program; and (b) the specialty in which the applicant is retrained must be consistent with the assignment for which the applicant is to be employed. OR Have a doctoral degree awarded between 1951 and 1978 from a regionally-accredited institution, with a dissertation primarily psychological in nature. (TRANSCRIPTS REQUIRED)
• Internships - (a) Have successfully completed a professional psychology internship training program that was accredited by APA or CPA at the time the program was completed and that is consistent with the assignment for which the applicant is to be employed. OR (b) New VHA psychology internship programs that are in the process of applying for APA accreditation are acceptable in fulfillment of the internship requirement, provided that such programs were sanctioned by the VHA Central Office Program Director for Psychology and the VHA Office of Academic Affiliations at the time that the individual was an intern; OR (c) VHA facilities that offered full-time, one-year pre-doctoral internships prior to PL 96-151 (pre-1979) are considered to be acceptable in fulfillment of the internship requirement; OR (d) Applicants who completed an internship that was not accredited by APA or CPA at the time the program was completed may be considered eligible for hire only if they are currently board certified by the American Board of Professional Psychology in a specialty area that is consistent with the assignment for which the applicant is to be employed. OR Applicants who have a doctoral degree awarded between 1951 and 1978 from a regionally-accredited institution with a dissertation primarily psychological in nature may fulfill this internship requirement by having the equivalent of a one-year supervised internship experience in a site specifically acceptable to the candidate's doctoral program. If the internship experience is not noted on the applicant's official transcript, the applicant must provide a statement from the doctoral program verifying that the equivalent of a one-year supervised internship experience was completed in a site acceptable to the doctoral program.
• Licensure - Hold a full, current, and unrestricted license to practice psychology at the doctoral level in a State, Territory, or Commonwealth of the United States, or the District of Columbia.

• (a) Experience. At least three years of experience as a professional psychologist, with at least one year equivalent to the GS-13 grade level.
• (b) Demonstrated Knowledge, Skills, and Abilities. In addition to the experience above, the candidate must demonstrate all of the following KSAs:
  • 1. Knowledge of and ability to understand and communicate existing policies and regulations.
  • 2. Knowledge of and ability to utilize resource materials as well as ability to develop new materials when needed.
  • 3. Ability to relate to individuals at many different levels both within and external to the organization.
  • 4. Ability to communicate effectively orally and in writing with a diverse group of professional staff.
  • 5. Ability to provide information about policy to various stakeholders or audiences in a useable and understandable manner.
  • 6. Ability to develop and recommend new or revised policies that are consistent with organizational goals and objectives.

• At Least five years of experience in the monitoring of compliance with Good Clinical Practices (GCP) for multicentered clinical trials.
• At least 5 years of experience in the auditing of compliance with Good Clinical Practices (GCP) for multicentered clinical trials.
• Have accreditation or certification as a Certified Clinical Research Associate (CCRA) through the Association of Clinical Research Professionals or Society of Clinical Research Associates (SOCRA).

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 MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Your application, résumé, C.V., and/or supporting documentation will be verified. Please follow all instructions carefully. Errors or omissions may affect consideration for 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.