The Research Pharmacy is a division within the Clinical Trials Office (CTO). This position reports directly to the Research Pharmacy Director who oversees all operations of investigational drug services ("Research Pharmacy") at Columbia University Irving Medical Center.
The CTO assists investigators and academic/research staff in developing clinical trials at P&S and provides administrative and clinical resources and infrastructure to build and sustain clinical trials research at P&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.
This position will have duties and responsibilities that include but are not limited to the following:
Coordinate all aspects of investigational drug supply (including all adult oncology clinical trials), maintain existing systems for management of investigational agents including perpetual inventories. Perform expiration date checks. Make recommendations for improving systems.
Ensure that medications are dispensed only upon a written order of an investigator and according to standard operating procedures and study protocols.
Write and follow applicable Standard Operating Procedures and study specific procedures. Write study specific procedures.
Maintain practice in accordance with JCAHO, FDA and other regulatory requirements.
Maintain study specific files and ensure that active protocols have been approved by an IRB, before dispensing. Maintain and follow each protocol regarding investigational drug use.
Dispense, manufacture, package investigational drugs upon written order of investigator, according to protocol. Maintain accountability records.
Dispense solid, liquid, and sterile dosage forms, including chemotherapy.
Maintain a safe, clean and orderly work environment.
Interact with University and Hospital staff, investigators, coordinators, sponsors, study monitors. Attend and host monitoring visits and/or meetings. Provide investigational drug information and write study specific procedures.
Position will supervise pharmacy technicians and other assistants.
Position will share on-call duties with other staff pharmacists.
Participate on at least one hospital committee (Oncology Protocol Review Board, Institutional Review Board, or other).
Works with chemicals, infectious agents, has contact with patients and/or research subjects.
Must have a Bachelor's degree or equivalent in education and experience, master's degree preferred.
Four years of related experience.
Minimum 1 year of hospital-based pharmacy experience or equivalent, such as pharmacy practice residency.
Current licensure from the New York State Board of Pharmacy or be eligible for licensure in the State of New York.
Must successfully complete systems training requirements.
Oncology Board Certification is a plus.
HIPAA Training, EH&S Training, Medical Surveillance
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 506496
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.