Pharmacist (Program Manager, Investigational Drugs & Controlled Substances)

Pharmacist (Program Manager, Investigational Drugs & Controlled Substances)

Department: Department of Veterans Affairs

Location(s): Indianapolis, Indiana

Salary Range: $132814 - $172660 Per Year

Job Summary: The Investigational Drug and Controlled Substance Program Manager works independently under the Associate Chief of Business Operations and is responsible for planning and coordinating pharmacy educational programs concerning investigational drugs, policies and controlled substance management for the Roudebush VA Medical Center Pharmacy Service.

Major Duties:

• VA Careers - Pharmacy: https://youtube.com/embed/Fn_ickNBEws Duties may include but not limited to: Program Management Investigational Drug Service: Maintains files of organized records, including drug accountability logs for investigational drugs, in accordance with applicable laws and regulations. Ensure all documentation is current and accurate. Maintains drug accountability logs and all required forms including, a general information sheet, VA studies check list, VA form 10-9012 (Investigational Drug Information Record), VA form 10-1223 (Report of Subcommittee on Human Studies), Clinical Impact, Continuing Review, approval, protocol, investigator's brochure-if provided, patient consent forms, and shipping and receiving documents. The investigational pharmacist maintains records for the receipt, storage and dispensing of all study medications. Plans, manages and coordinates all the administrative requirements of each investigational drug protocol. Ensures that all the required preparatory documents have been completed prior to study initiation. Coordinates with Pharmacy Service to ensure resources are adequate to provide the necessary services for each investigational drug protocol. For those protocols where monetary reimbursements can be realized for Pharmacy Research Service activities, prepares the proper paperwork and ensure the transfer of funds occurs. Serves on the VA Research and Development Committee (R&D Committee) and the IUI Institutional Review Board(s) (IRB) as a Pharmacist and VHA reviewer as necessary Program Management Controlled Substances: Performs all controlled substance activities necessary to comply with all federal, state, and local controlled substance agencies and regulations and the VA Controlled Substance Policy. These include, but aren't limited to: inventory management, security of vault, and disposal of controlled substances. This position will have oversight of all programmatic functions related to controlled substances at all sites of care to include the Opioid Substitution Clinic. This position will have oversight of the all-hazards emergency cache to include controlled and non-controlled stock and compliance surrounding this program. Assist in the development and revision of policies and procedures and participate in medical center and departmental goal planning and quality improvement activities. Dispenses prescription pads to medical center providers timely and within established accountability procedures in accordance with VHA Handbook 1108.2. Ensures that all written policies and procedures and drug studies conform to VHA, DEA, FDA, Joint Commission, and external accreditation organizations. Ensures that all protocols have received the proper approvals prior to initiation of each study. Clinical: Provides consultation to physicians, nurses, and other healthcare professionals concerning drug administration, interactions, and contraindications regarding drugs involved in investigational protocols. Responsible for handling drug information requests related to the investigational agents. Coordinates with study staff in evaluation of patients' ability to understand instructions on investigational drug therapy. Provides oral and written counseling to assure full understanding of drug therapy. Assists investigator transitioning care back to clinicians upon termination of investigational drug treatment. Education/Training: Participates in meetings, conferences, and training programs relevant to the development and maintenance of the Controlled Substance Program, and research department as it pertains to pharmacy. Identify continuing education, training needs, etc. for Pharmacy staff and respond to those needs by conducting on-the-job, in-services, etc to ensure safety and quality control in the delivery of drug products and an understanding of the Pharmacy Service policies and procedures. Provides education to Pharmacy Service and other health care providers regarding controlled substances and drugs involved in investigational protocols. Research: Actively works to add to the body of knowledge by supporting the research and quality improvement initiatives of Pharmacy Service, residents, other clinical pharmacy staff and other practitioners within the facility and/or network Acts as a principal or other investigator in research within area of interest Work Schedule: Monday - Friday, 7:00am - 3:30pm Compressed/Flexible: Not Available Telework: Not Available Virtual: This is not a virtual position. Functional Statement #: 92949-0 Relocation/Recruitment Incentives: Not Authorized Permanent Change of Station (PCS): Not Authorized PCS Appraised Value Offer (AVO): Not Authorized

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. 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. Education: (1) 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 1 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). Grade Determinations: The following criteria must be met when determining the grade of candidates. Experience. In addition to the GS-12 requirements, must have 1 year of experience equivalent to the next lower grade level. Demonstrated Knowledge, Skills, and Abilities (KSAs): Pharmacists assigned to this position must demonstrate, in their resume, 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. Preferred Experience: 1-3 years prior program management experience and/or working with regulatory agencies such as DEA, OIG, SAHMSA Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/. The full performance level of this vacancy is 13. The actual grade at which an applicant may be selected for this vacancy is 13. Physical Requirements:none

How to Apply: All applicants are encouraged to apply online. To apply for this position, you must complete the full 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 12/22/2025 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12852135. To begin, click Apply Online to create a USAJOBS 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.

Application Deadline: 2025-12-22