This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP application within four months of appointment. Program Approval, award amount (up to $200,000) & eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after review of the EDRP application. Former EDRP participants ineligible to apply.

Duties

VA Careers - Pharmacy: https://youtube.com/embed/Fn_ickNBEws Facility Program Manager (Investigational Drug Service) GS-0660-13 Duties include but are not limited to the following description: The Investigational Drug Service Program Manager is a licensed pharmacist who manages the Investigational Drug Service and coordinates research related pharmacy services for all approved research studies involving drugs. They provide clinical, operational, and regulatory expertise and guidance related to drugs used in human and animal research studies in order to optimize safety, quality, and compliance. They develop, coordinate, supervise, and evaluate the activities of the Investigational Drug Service and collaborates with investigators, research staff, sponsors, monitors, affiliates, regulatory agencies, clinical providers, and members of the Research and Pharmacy Services. They act under the administrative supervision of the Associate Chief, Pharmacy Operations. They participate in the Human Studies Subcommittee in order to provide pharmacy support and representation. Basic program guidance and oversight is received jointly from the Associate Chief, Pharmacy Operations and the Associate Chief of Staff, Research Service. The incumbent manages the Investigational Drug Service, assuring compliance with VA and FDA regulations including VHA 1108.04 "Investigational Drugs and Supplies", VHA Handbook 1200.5 "Requirements for the Protection of Human Subjects in Research", and The Code of Federal Regulations, Title 21. In addition, the incumbent ensures that the Investigational Drug Service meets accreditation requirements set forth by the Joint Commission (JC) and the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Pharmacists assigned to this position must demonstrate the following KSAs: Ability to communicate orally and in writing to persuade and influence clinical and management 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. Work Schedule: Monday-Friday 7:00am-3:30pm Telework: Ad-Hoc Available. Virtual: This is not a virtual position. Functional Statement #: 000000 Relocation/Recruitment Incentives: Not Authorized. EDRP Authorized: Former EDRP participants ineligible to apply for incentive.Contact [email protected], the EDRP Coordinator for questions/assistance. Learn more Permanent Change of Station (PCS): Not Authorized.

Requirements

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. English Language Proficiency: Candidates must be proficient in spoken and written English to be appointed as authorized by 38 U.S.C. 7403(f) 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 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: Facility Program Manager (Investigational Drug Service) GS-0660-13 Experience: In addition to the basic requirements, candidates must meet one of the following: 1 year of experience at or equivalent to the next lower grade level (GS-12) Completion of an ACPE-accredited Pharm.D. program Functions of the position include but are not limited to: A. CLINICAL PATIENT CARE SKILLS Provides consultation to physicians, nurses, and other health professionals concerning the usage, administration, contraindications, precautions, and interactions of drugs used in research protocols. Evaluates information provided to research participants regarding the effects, usage, risks, precautions, and special instructions for drugs used in research studies. Considers the age specific requirements of adult and geriatric patients, including the need for dose adjustment, presence of comorbidities, ability to understand and retain instructions, hearing and visual impairments, and any other conditions relevant to the age of the patient when assessing and providing patient care. B. MEDICATION DISPENSING AND DISTRIBUTION Ensures required approvals and documents are in place prior to dispensing (e.g., R&D Committee approval, consent form, order from authorized prescriber). Participates in the order, receipt, custody, preparation, distribution, and dispensing of investigational drugs for VACHS, including coordination of studies with other institutions as required. Assures separation of duties are maintained per VA regulations to assure that 2 different individuals are involved in the ordering and receiving process. Specifically, one person for the procurement and a different person for the receipt . Maintains records of receipt, dispensing, and disposal of investigational drugs according to VA regulations. C. ADMINISTRATIVE & PROGRAM MANAGEMENT Freely and willingly provides the necessary technical knowledge and assistance as required to support the inpatient and outpatient pharmacy operations. The Program Manager will also be expected to willingly exchange ideas, assist and provide support as a "team player" with the pharmacy staff and actively seek and maintain face-to-face contact in the usual work areas with other members of Pharmacy Service. Manages the Investigational Drug Service and is responsible for the receipt, custody, preparation, distribution, and documentation of drugs used under approved research protocols. Coordinates pharmacy services for animal research labs, including procurement, distribution, and monitoring of all controlled substances used in animal labs in the medical center, and procurement of other approved drugs by request. Prepares an itemized estimate of charges for drugs, supplies, and Research Pharmacy Services for new protocol and grant submissions, and prepares quarterly invoices for purchases and services for all active protocols. D. EDUCATION AND TRAINING Completes all mandatory training as required by local, VISN and national mandates within established timeframes and submits documentation of training to the Pharmacy Service Administrative Assistant. Assures timely completion of all internally assigned employee education modules as presented via Talent Management Service (TMS). Assists investigators and research staff with study design, protocol submissions, and regulatory requirements, as needed. Assists in completing VA form 10-9012 (Investigational Drug Information Record), when required, and the Drug Review Checklist. Facilitates meetings, site visits, and audits of the Investigational Drug Service by sponsors, monitors, VACHS Research Compliance officers, regulatory agencies, and other authorized parties. E. RESEARCH AND QUALITY Contributes to the body of knowledge by supporting the research and quality improvement initiatives of the Pharmacy Service, Pharmacy Residency Program, and other practitioners within the facility and/or network. F. SAFETY The Program Manager will work safely in performing all assigned tasks, being mindful to follow applicable safety rules and regulations and reporting all unsafe acts, conditions and personal injuries to the supervisor immediately. The Program Manager will attend safety training and continuing education as required. In addition, he/she will demonstrate knowledge of roles and responsibilities regarding Medical Center and Service safety management plans. Preferred Experience: Inventory management/Pharmaceutical Procurement Sterile IV Compounding Experience Controlled Substance handling and accountability experience Familiarity with electronic records management Strong communication skills, both written and verbal Research experience Familiarity with government regulatory agencies such as FDA and DEA Collaborative Institutional Training Initiative (CITI Program) Training Certificate Proficient in Microsoft Office (Microsoft Word, Excel, PowerPoint and Outlook, products) Reference: For more information on this qualification standard, please visit https://www.va.gov/ohrm/QualificationStandards/. Physical Requirements: Moderate lifting and carrying (15-44 pounds); straight pulling (1 hour); pushing (1 hour) reaching above shoulder; use of fingers; both hands required; walking (2 hours); standing (2 hours); repeated bending (2 hours); both legs required; ability for rapid mental and muscular coordination simultaneously; near vision correctable at 13" to 16" to Jaeger 1 to 4; far vision correctable in one eye to 20/20 and to 20/40 in the other; ability to distinguish basic colors; ability to distinguish shades of colors; hearing (aid permitted).

Education

IMPORTANT: 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: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.

Contacts

• Address West Haven VA Medical Center 950 Campbell Avenue West Haven, CT 06516 US
• Name: Heather Volpe
• Email: [email protected]