• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $120,000 - $130,000

Position Summary

The Research Pharmacy is a division within the Clinical Trials Office (CTO). This position reports directly to the Research Pharmacy Senior Director who oversees all operations of Research Pharmacy (RP) at Columbia University Irving Medical Center.

The CTO assists investigators and academic/research staff in developing clinical trials and provides administrative and clinical resources and infrastructure, to build and sustain clinical trials research at VP&S.

The successful candidate will provide essential investigational drug services to Investigators and Research Personnel with responsibilities, critical and central to the conduct of the clinical investigation according to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements.

Responsibilities

• Coordinate all aspects of investigational drug services including drug receipt, inventory control, drug dispensation, and drug return.
• Follow applicable Standard Operating Procedures and study specific procedures.
• Maintain practice in accordance with JCAHO, FDA, and other regulatory requirements.
• Provide cross coverage in all areas of RP including adult and pediatric oncology and general clinical trials, as deemed necessary by the director of RP.
• Maintain existing systems for management of investigational product inventories and perform expiration date checks.
• Conduct Site Initiations (SIV) visits.
• Write study specific procedures.
• Meet protocol requirements for investigational drug use.
• Maintain study specific files.
• Dispense, compound, and package investigational drugs upon written order of investigator, and according to the IRB approved protocol.
• Maintain drug accountability records.
• Dispense all dosage forms necessary to meet the needs of protocols.
• Dispense non-hazardous and hazardous sterile products, such as chemotherapy, intrathecal, vaccine, and gene therapy.
• Maintain a safe, clean, and orderly work environment.
• Collaborate with University and Hospital staff, investigators, coordinators, sponsors, and study monitors.
• Attend and host monitoring visits and/or meetings as needed.
• Provide investigational drug information.
• Share on-call duties with other pharmacists based on a rotating schedule.
• Performs related duties & responsibilities as assigned/requested.

Minimum Qualifications

• Must have a Bachelor's degree or equivalent in education and experience, master's, or Pharm.D degree preferred.
• Four years of related experience
• Current licensure from the New York State Board of Pharmacy or be eligible for licensure in the State of New York.
• Must possess the ability to successfully complete all training requirements including but not limited to Epic systems training, Research Pharmacy IT training, aseptic technique training, and hazardous training.

Preferred Qualifications

• Board Certification is a plus.

• Minimum 1 year of hospital-based pharmacy experience or equivalent, such as pharmacy practice residency.