Description
Penn 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.
Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?
Penn Medicine is seeking a full-time, day shift Clinical Research Pharmacist, Investigational Drug Services for the Hospital of the University of Pennsylvania (HUP).
Summary:
- The clinical research pharmacist within investigational drug services oversees coordinating, collaborating and providing expertise in support of clinical investigational drug trials. The individual will be responsible for managing the preparation, storage, dispensing, and documentation of investigational drugs used in clinical trials. The individual will ensure compliance with regulatory guidelines, maintain protocol adherence, and collaborate with researchers to support study integrity. The individual must demonstrate a highly organized ability to integrate within the healthcare team and current structure of the pharmacy department. The clinical research pharmacist will maintain pharmacy study summary, protocol, dispensing procedures, completed samples of required paperwork, dispensing checklist, fee schedule, billing procedures for relevant investigational trials.
Responsibilities:
- Prepares, compounds and dispenses medications, biologic agents, natural products, medical devices and related materials for ongoing research trials. Accurately dispenses medications and prepares sterile products following proper aseptic technique under USP 797/800 and hospital policies and procedures.
- 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.
- Reads, interprets and processes prescriptions for investigational medications
- clarifies orders with prescribers as needed. Ensures the accuracy and integrity of products prior to their dispensing to study participants.
- 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.
- Maintains compliance with all applicable Penn and UPHS policies, sponsor guidelines and state and federal laws and regulations.
- Prepares written study procedures for new trials, which accurately reflect the protocol regimen and sponsor’s specific requirements
- updates procedures to correspond to protocol revisions.
- Oversee 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 and performs related duties as required and assigned by the manager.
Credentials:
- Pennsylvania Pharmacist Licensure (Required)
Education or Equivalent Experience:
- Bachelor's of Science in Pharmacy or PharmD obtained from an accredited school of pharmacy (Required)
- And 1+ years Hospital pharmacy experience (Preferred)
- PGY1 training, Prior clinical trials experience (Preferred)
- PGY2 training, Investigational drug services (Preferred)
We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.
Live Your Life's Work
We are an Equal Opportunity 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.
