Director, Investigational Drug Section

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval.

The START Center for Cancer Research is seeking a Director, Investigational Drug Section who is responsible for overseeing all components of IDS operations at the assigned site. Additionally, the director should fulfill all existing clinical pharmacist job duties. This includes all facets of medication order verification, dispensing and documentation process for investigational drugs, conventional chemotherapy and supportive care medications provided by the IDS.

The pharmacist may be involved in the provision of pharmaceutical care including assisting with patient interviews, maintenance of current medication lists, providing patient medication education, providing drug information to the healthcare team and patients. The pharmacist will practice with a high degree of autonomy, guided by IDS SOPs and quality assurance verification guidelines. This role is responsible for the daily supervision of staff assigned to medication preparation, dispensing, and operation of the IDS in accordance with all applicable rules and regulations.

The director will serve as a direct supervisor to all site-specific pharmacy team members including other pharmacists and pharmacy technicians.

• Partner with Director,Nursing and study operations leader to ensure efficient,high quality
  patient care ismaintainedand prioritized

• Collaborate with site leadership team, shared servicesleadersand integration team members to promote alignment in workflows and processes

• Ensure adherence to all local/federal expectations for IDS space, ensure compliance withall applicable internalSOPs

• Verify medication orders including accuracy of dosages and calculations, review of basic patient eligibility criteria, including but not limited to accurately signed / dated study consent form(s), laboratory values within treatment criteria, all appropriate tests have been completed, resolution of known toxicity from previous chemotherapy, and an absence of serious known drug interactions.

• Oversee the preparation and dispensing of all medications from the IDS, including supervision of certified pharmacy technicians during preparation of IV admixtures and oral medication dosages, insuring compliance with all steps of the double-check verification process prior to releasing dosages from the IDS.

• Provide pharmaceutical care including patient medication and supportive carecounseling, anddrug information to the healthcare team and patients.

• Oversee drug inventories including documentation of current inventory, projection of expected usage in concert with ordering, receiving, storage and dispensation tracking of Phase I and conventional medications.

• Assist pharmacy technicians inmaintainingadequate investigational documentation, records, weekly inventory, and interactions with study personnel

• Review new protocol(s), protocolamendmentsand associated forms.

• Maintain and generate reports using the IDS drug accountability program.

• Contribute to the effective operation of the pharmacy department. Enteraccuratemedication computer order entries andaccuratemaintenance of reported patient home medications in the EMR.

• Graduate of an ACPE accredited School of Pharmacy.

• Current State license.

• Previous hospital/clinic pharmacy experience.

• Familiarity with sterile compounding requirements for chemotherapy agents, USP, USP, laminar airflow hood(s) / biological safety cabinet(s); telephone and copier / scanner / facsimile machine.

• Computer skills, including use
  
  Microsoft Office products, including Word, Excel, Power Point and Access.

• Familiarity with the use of electronic medical record program(s), pharmacy softwareprogramsand study IRT systems.

• Knowledge of Good Clinical Practice (GCP) principles.

• Sterile compounding & chemotherapy certification.

• Intravenous sterile product training.

• Prior experience in clinical trials and management of investigational drugs.

• Specialty residency…