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Research/Controlled Substance Pharmacist

  • Job ID: 275606265
  • Status: Part-Time
  • Regular/Temporary: Regular
  • Hours: Daylight and Evenings
  • Shift: Day Job
  • Facility: UPMC Children's Hospital of Pittsburgh
  • Department: Pharmacy
  • Location: 4401 Penn Avenue, Pittsburgh PA 15224
  • Union Position: No
  • Salary Range: $44.41 to $75.36 / hour

Description

Purpose:
Coordinate the implementation, dispense and document of investigational drug studies and stock and dispense of controlled substances. Act as the department resource for the staff on issues related to investigational drug studies and controlled substances.

Responsibilities:
  • In conjunction with Director of Pharmacy and Director of Research, establish budget or fee schedule for studies and collects dispensing and handling fees as appropriate. Prepare financial reports to appropriate administrative personnel as required.
  • Primary study materials will be chemotherapy/antineoplastic and/or a NIOSH hazardous medication class.
  • Establish and maintain standards which assure the quality, proper storage and safe use of all investigational agents and related supplies.
  • Establish and maintain adequate and easily retrievable record keeping systems for protocols, study subjects, drug inventory, manufacturing and dispensing of investigational drugs.
  • Represent the Pharmacy Department, establishes and maintains a liaison relationship with the Human Rights Committee (IRB), SCRO and principal investigators.
  • Insure that paperwork is completed and retained and that investigational and study drugs are handled according to the requirements of the FDA and/or sponsoring agencies.
  • Prepare education drug monographs for investigational or study drugs for nursing staff as needed. In addition, prepare protocol summaries, drug data sheets and other documents for pharmacy personnel.
  • Help establish and maintain quality assurance program(s) for investigational & study drugs and controlled substances.
  • Prepare and submit accurate reports to appropriate administrative personnel as required.
  • Provide randomization, blinding, pharmaceutical compounding and other consultative activities to principal investigators.
  • Develop step-by-step procedures for preparation, dispensing and distribution of investigational and study drugs. Develop codes, labels and other pre-defined formats for pharmacy computer entry.
  • File all appropriate paper work with the IDEA or FDA and reports to regulatory agencies unresolved discrepancies as outlined in applicable laws and regulations.
  • Develop staff training programs regarding investigational and study drug procedures. Train professional and non-professional personnel in the preparation of these agents, labeling and appropriate record keeping and dispensing and kit utilization.
  • Coordinate the ordering and stocking of investigational and study agents as needed to maintain adequate inventory levels. Coordinate the removal and disposal of expired stock or stock from completed or terminated studies. Insure that this work is done according to FDA, protocol guidelines or department policy.
  • Monitor the use of controlled substances & investigational drugs and resolve all discrepancies. This includes at least weekly inventory audits to verify accuracy of inventory levels of pharmacy's controlled substances and investigational drug supplies and unannounced audits of nursing stations for compliance of federal regulations and hospital policies.
  • Ensure compliance with all federal and state regulations concerning controlled substances and investigation drugs.
  • Meet with investigators, study coordinators, study monitors and others in coordinating study logistics. After a review of investigational drug or drug study protocols, determines pharmaceutical materials and professional services necessary to satisfy the requirements of the study.
  • Ensure patient safety through reviewing investigational drug protocols for appropriateness of drug dosage, regimen, concentration, stability, and drug interaction potential; alert primary investigator if these protocol parameters are inappropriate.

Qualifications

  • B.S. degree in Pharmacy or Doctor of Pharmacy (Pharm D.) required. 
  • 3 years experience in hospital pharmacy required.
  • Pharm.D. or Master's degree with residency preferred.
  • Experience in a pediatric hospital pharmacy preferred.
  • Analytical/problem solving ability necessary to participate in development of department procedures and goals, participate in the analyses of operational problem and proposals and direct inventory control.
  • Interpersonal skills necessary to interact with all levels of hospital personnel communicate with vendors and cooperate with the nursing and medical staffs.
  • Self-motivated and able to work independently. 
  • Ability to prioritize tasks, manage multiple projects and complete assigned tasks in a timely manner.
  • Personal computer skills including, but not limited to, Microsoft Office.

Licensure, Certifications, and Clearances:
CITI - Collaborative Institutional Training Initiative Certification required

  • Pharmacist
  • Act 33 with renewal
  • Act 34 with renewal
  • Act 73 FBI Clearance with renewal

  • UPMC is an Equal Opportunity Employer/Disability/Veteran

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