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 , the EDRP Coordinator for questions/assistance.
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Permanent Change of Station (PCS): Not Authorized.
Requirements
Conditions of Employment
- You must be a U.S. Citizen to apply for this job.
- All applicants tentatively selected for VA employment in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied employment with VA.
- Selective Service Registration is required for males born after 12/31/1959.
- Must be proficient in written and spoken English.
- 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.
- Must pass pre-employment physical examination.
- Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP).
- Participation in the Coronavirus Disease 2019 (COVID-19) vaccination program is a requirement for all Veterans Health Administration Health Care Personnel (HCP) - See "Additional Information" below for details.
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/.
Benefits
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Review our benefits
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
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, resume, 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.
The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.
It is the policy of the VA to not deny employment to those that have faced financial hardships or periods of unemployment.
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.
Required Documents
To apply for this position, you must provide a complete Application Package which includes:
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 ensure you have included all documents required for your application, such as a copy of your transcript (if using education to qualify), SF-50's (current/former Federal employees), etc.
- Cover Letter
- DD-214/ Statement of Service
- Disability Letter (Schedule A)
- Disability Letter (VA)
- License
- Other (1)
- PCS Orders
- Performance Appraisal
- Professional Certification
- Resume
- Separation Notice (RIF)
- SF-15
- SF-50/ Notification of Personnel Action
- Transcript
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
Feds Hire Vets - Veterans - Job Seekers - Veterans' Preference.
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.
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 01/07/2025 to receive consideration. To preview the questionnaire click https://apply.usastaffing.gov/ViewQuestionnaire/12642001.
- 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.
To verify your application is complete, log into your USA JOBS account,
https://my.usajobs.gov/Account/Login, select the Application Status link and then select the more information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. To return to an incomplete application, log into your USA JOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USA JOBS account or your application will be incomplete.
Next steps
Once your online application is submitted you will receive a confirmation notification by email. After we receive application packages (including all required documents) and the vacancy announcement closes, we will review applications to ensure qualification and eligibility requirements are met. After the review is complete, a referral certificate(s) is issued and applicants will be notified of their status by email. Referred applicants will be notified as such and may be contacted directly by the hiring office for an interview. All referred applicants receive a final notification once a selection decision has been made.
You may check the status of your application at any time by logging into your USA Jobs account and clicking on Applications. Information regarding your application status can be found in the USAJobs Help Center.
NOTE: Participation in the seasonal influenza program is a condition of employment and a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). It is a requirement that all HCP to receive annual seasonal influenza vaccination or obtain an exemption for medical or religious reasons. Wearing a face mask is required when an exemption to the influenza vaccination has been granted. HCP in violation of this directive may face disciplinary action up to and including removal from federal service. HCP are individuals who, during the influenza season, work in VHA locations or who come into contact with VA patients or other HCP as part of their duties. VHA locations include, but are not limited to, VA hospitals and associated clinics, community living centers (CLCs), community-based outpatient clinics (CBOCs), domiciliary units, Vet centers and VA-leased medical facilities. HCP include all VA licensed and unlicensed, clinical and administrative, remote and onsite, paid and without compensation, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, researchers, volunteers and health professions trainees (HPTs) who are expected to perform any or all of their work at these facilities. HPTs may be paid or unpaid and include residents, interns, fellows and students. HCP also includes VHA personnel providing home-based care to Veterans and drivers and other personnel whose duties put them in contact with patients outside VA medical facilities.