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.
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.
Open to current, permanent employees of the Richard L. Roudebush VA Medical Center & subsidiary CBOCs; and past/current/upcoming VA Health Professional Trainees (HPTs) of related educational field.
NOTE: The 2-page Resume requirement does not apply to this position. For more information, refer to Required Documents below.
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
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.
Subject to background/security investigation.
Selected applicants will be required to complete an online onboarding process. Acceptable form(s) of identification will be required to complete pre-employment requirements (https://www.uscis.gov/i-9-central/form-i-9-acceptable-documents). Effective May 7, 2025, driver's licenses or state-issued dentification cards that are not REAL ID compliant cannot be utilized as an acceptable form of identification for employment.
Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP).
Complete all application requirements detailed in the "Required Documents" section of this announcement.
As a condition of employment for accepting this position, you will be required to serve a 1 or 2-year trial period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider:
your performance and conduct;
the needs and interests of the agency;
whether your continued employment would advance organizational goals of the agency or the Government; and
whether your continued employment would advance the efficiency of the Federal service.
Upon completion of your trial period, your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.
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
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
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/.
Additional information
Receiving Service Credit or Earning Annual (Vacation) Leave: Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee. Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.
During the application process you may have an option to opt-in to make your resume available to hiring managers in the agency who have similar positions. Opting in does not impact your application for this announcement, nor does it guarantee further consideration for additional positions.
This job opportunity announcement may be used to fill additional vacancies.
This position is in the Excepted Service and does not confer competitive status.
VA encourages persons with disabilities to apply. The health-related positions in VA are covered by Title 38, and are not covered by the Schedule A excepted appointment authority.
If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement.
VA Healthcare System Serving Ohio, Indiana and Michigan (VISN 10) advocates for a Whole Health System of care in each of the Medical Centers. This is an approach to healthcare that empowers and equips people to take charge of their health and well-being and live their lives to the fullest. As an employee operating in a Whole Health System of care, you will operate in a model with three core elements, seeking to create a personalized health plan for each Veteran. This is done in the context of healing relationships and healing environments and a connection back to the Veteran's community. This aligns with the Veterans Health Administration (VHA) Mission Statement to Honor America's Veterans by providing exceptional health care that improves their health and well-being.
Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.
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.
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.
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.
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.
To apply for this position, you must provide a complete Application Package which includes:
License
Resume
SF-50/ Notification of Personnel Action
Transcript
Special Note for Applications: To complete your application, please use the following link https://vacareers.va.gov/wp-content/uploads/sites/5/Resume.docx to download the standard Clinical Resume Document. This one-page document does not need to be modified and must be uploaded into the two-page restricted 'Resume' document upload field.
Your full resume/CV may be uploaded without page limitation into the 'Other' document upload field.
The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please 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)
Other (2)
Other (3)
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.
Veterans' preference does not apply for internal or other current permanent Federal agency employees.
If you are relying on your education to meet qualification requirements:
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.
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.
Richard L Roudebush VA Medical Center
1481 West Tenth Street
Indianapolis, IN 46202
US
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.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
To apply for this position, you must provide a complete Application Package which includes:
License
Resume
SF-50/ Notification of Personnel Action
Transcript
Special Note for Applications: To complete your application, please use the following link https://vacareers.va.gov/wp-content/uploads/sites/5/Resume.docx to download the standard Clinical Resume Document. This one-page document does not need to be modified and must be uploaded into the two-page restricted 'Resume' document upload field.
Your full resume/CV may be uploaded without page limitation into the 'Other' document upload field.
The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please 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)
Other (2)
Other (3)
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.
Veterans' preference does not apply for internal or other current permanent Federal agency employees.
If you are relying on your education to meet qualification requirements:
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.
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.
Richard L Roudebush VA Medical Center
1481 West Tenth Street
Indianapolis, IN 46202
US
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.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
