Director, Investigational Drug Section

START Center for Cancer Research•Virginia Beach, VA

1d•Hybrid

About The Position

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. 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.

Requirements

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<797>, USP<800>, 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 software programs and 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.

Nice To Haves

Specialty residency in oncology and/or current BPS Board Certified Oncology Pharmacist (BCOP).

Responsibilities

Partner with Director, Nursing and study operations leader to ensure efficient, high quality patient care is maintained and prioritized.
Collaborate with site leadership team, shared services leaders and integration team members to promote alignment in workflows and processes .
Ensure adherence to all local/federal expectations for IDS space, ensure compliance with all applicable internal SOPs.
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 care counseling, and drug 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 in maintaining adequate investigational documentation, records, weekly inventory, and interactions with study personnel .
Review new protocol(s), protocol amendments and associated forms.
Maintain and generate reports using the IDS drug accountability program.
Contribute to the effective operation of the pharmacy department.
Enter accurate medication computer order entries and accurate maintenance of reported patient home medications in the EMR.