Apply on Employer Site

USAJOBS · 3 weeks ago

Pharmacist (Program Manager, Investigational Drugs & Controlled Substances)

Indianapolis, Indiana, USA

Full-time

Onsite

Mid, Senior Level

$133K/yr - $173K/yr

4+ years exp

USAJOBS is seeking a Pharmacist (Program Manager, Investigational Drugs & Controlled Substances) to work at the Richard L Roudebush VA Medical Center. This role involves planning and coordinating pharmacy educational programs, managing investigational drugs, and overseeing controlled substance activities in compliance with regulations.

ConsultingGovernmentHuman ResourcesInformation TechnologyInternetStaffing Agency

No H1B

U.S. Citizen Only

Responsibilities

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

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

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

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

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

Qualification

Pharmacy degreePharmacist licenseProgram managementRegulatory complianceClinical pharmacy expertiseCommunication skillsProblem-solving skillsTeam collaboration

Required

U.S. Citizenship

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

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

Must be proficient in written and spoken English

Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP)

Must complete all application requirements detailed in the 'Required Documents' section of this announcement

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