Job ID: 145417
Work Type: FT
Location: Philadelphia, PA, United States
Date Posted: Sep 1, 2022
Work Schedule: Days
DescriptionPenn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.
Summary of Responsibilities:
· Prepares, compounds, manufactures and dispenses medications, biologic agents, natural products, medical devices and related materials for ongoing research trials.
· Manages recordkeeping, shipping, ordering, receiving, storage, retention/destruction and related inventory activities in compliance with good clinical practices and the requirements of individual study sponsors.
· Participates in study initiations, monitoring and closeout visits, quality assurance audits and other related meetings with study sponsors and their representatives, regulatory agencies and others.
· Ensures the accuracy and integrity of products prior to their dispensing to study participants.
· Maintains compliance with all applicable Penn and UPHS policies, sponsor guidelines and state and federal laws and regulations.
· Reads, interprets and processes prescriptions for investigational medications; clarifies orders with prescribers as needed.
· Accurately dispenses medications and prepares sterile products following proper aseptic technique.
· Serves as a resource to other members of the research community as well as to UPHS pharmacists and nurses; provides drug information for investigational agents as needed; assists investigators in the development of investigator-initiated trials, formulation of medications and preparation of IND applications.
· Prepares clearly written staff procedures for new trials, which accurately reflect the protocol regimen and sponsor’s specific requirements; updates procedures to correspond to protocol revisions.
· Oversees the work performed by clinical research technicians, pharmacy interns, pharmacy residents and clerkship students to ensure that performance standards are maintained and that work is accurate in accordance with applicable state and federal regulations and Penn and UPHS policies.
· Participates in rotating on-call coverage for situations that require assistance after hours.
· Performs related duties as required and assigned by manager.
Licensure as a pharmacist (State of Pennsylvania) required at time of hire or ability to reciprocate
Successful completion of CITI Protection of Human Subjects training during probationary period and reassessment periodically as per University policy
Education or Equivalent Experience:
PharmD or other advanced degree
Pharmacy residency or fellowship preferred
Prior clinical trials experience (will consider non-clinical research experience)
Previous experience working with investigational medications or devices preferred
Previous medication compounding and formulation experience preferred
Sterile product preparation experience prior to hire and demonstrated ability to prepare sterile products accurately and safely after hire
We are an Equal Opportunity and Affirmative Action employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.