Summary

The VA Cooperative Studies Program (CSP) is part of the division of the Office of Research and Development - VA Central Office and is responsible for the planning and conducting of large multicenter controlled clinical trials (MCTs). CSP maintains a diverse portfolio of clinical research studies that seeks to provide definitive answers to important clinical questions on a national scale and on a range of diseases that affect Veterans and the nation.

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. (NOTE: This applies to the past - current - and upcoming VA Health Professional Trainees (HPT) only. HPT is an individual appointed to temporary positions in one or more VHA medical facilities performing clinical or research training experiences to satisfy program or degree requirements or receiving VA Health Professional Scholarship Program. HPTs can be either VA-paid or Without Compensation (WOC).)

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 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.) 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
• The pharmacist must maintain current registration if this is a requirement for maintaining full - current - and unrestricted licensure
• A pharmacist who has - or has ever had - any license(s) revoked - suspended - denied - restricted - limited - or issued/placed in a probationary status may be appointed only in accordance with the provisions in VA Handbook 5005 - Part II - Chapter 3 - section B - paragraph 16
• May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria)
• May qualify based on being covered by the Grandfathering Provision as described in the VA Qualification Standard for this occupation (only applicable to current VHA employees who are in this occupation and meet the criteria)
• Grade Determinations: Experience: GS-13: In addition to the GS-12 requirements - must have 1 year of experience equivalent to the next lower grade level
• Experience includes but is not limited to: reviewing - interpreting - and verifying medication orders for appropriateness
• processing and filling medication orders
• interacting with and making recommendations to other clinical staff regarding medication therapy ordered to ensure safe and effective care
• reviewing the patient's medications - allergies - labs - and other pertinent information from the medical record to identify and solve medication-related problems
• contacting providers as appropriate
• documenting recommendations and interventions
• providing refill extensions and partial medication supplies
• taking health and medication histories
• performing medication reconciliation
• providing drug information
• assisting in formulary management including therapeutic substitutions - nonformulary reviews and medication usage evaluations
• documenting and assessing adverse drug events (ADEs)
• assisting in medical emergencies
• providing oversight of technical staff in all aspects of medication distribution
• Pharmacists assigned to this position must also demonstrate the following KSAs: Ability to communicate orally and in writing to persuade and influence clinical and management decisions
• Expert understanding of regulatory and quality standards for their program area
• Ability to solve problems - coordinate and organize responsibilities to maximize outcomes in their program area or area of clinical expertise
• Expert knowledge of a specialized area of clinical pharmacy practice or specialty area of pharmacy
• Advanced skill in monitoring and assessing the outcome of drug therapies - including physical assessment and interpretation of laboratory and other diagnostic parameters
• Reference: For more information on this qualification standard - please visit https://www.va.gov/ohrm/QualificationStandards/
• The full performance level of this vacancy is GS-13
• Physical Requirements: The work is primarily performed while sitting - though some work may require periods of standing
• The regular and recurring work of this position involves sitting at a desk - conference - meetings - etc
• Optional need to participate in distribution of materials that may require some lifting of small weight boxes (25 lbs.).

Duties

• The duties of this position include - but are not limited to: Performing quality assurance work that involves systematic prevention of defects - nonconformance to regulatory requirements and standards - identification of unsatisfactory trends and conditions - and correction of factors that may contribute to defective work processes for clinical supplies
• Effectively interacting with accreditation - regulatory (FDA/DEA) - and ISO officials and reports and evaluates data as required
• Utilizes established data management tools to ensure continuous survey/audit inspection readiness activities
• Supports continuous survey/audit inspection readiness activities - including but not limited to supporting alignment with ISO standards (ISO 9001 - 21500) - standard operating procedures - cGMP regulations (21 CFR 210 and 211) - and Joint Commission standards - assisting in completion of all accreditation process requirements in a timely manner
• Developing plans and programs for achieving and maintaining clinical supply quality throughout the life cycle of the clinical supplies
• Researching benchmark program documentation - standards and measurement criteria
• Work Schedule: Monday - Friday - 7:30 - 4:00 Telework: Available Virtual: This is not a virtual position
• Functional Statement #: 615760 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized