As an integral member of the University of Hawai\u00c4\u00a5 Cancer Center, the Investigational Cancer Drug Pharmacistperforms responsibilities that enhance the department\u2019s reputation and service orientation. Duties include activities required for a pharmacist in charge as defined under board of pharmacy requirements of Hawai\u00c4\u00a5; coordinating, collaborating, and providing expertise in support of clinical investigational drug trials; fulfilling educational responsibilities; dispensing medication accurately and efficiently; managing administrative duties; providing direct and/or functional supervision; maintaining overall responsibility for pharmacy operations in the assigned area; handling communication tasks; performing cross-functional duties, including those of the compounding sterile preparations, Patient Care Assessment; and fulfilling other duties consistent with the job classification as required.
ESSENTIAL JOB DUTIES AND FUNCTIONS
Pharmacy Administrative
- Ensures compliance with the State of Hawai\u00c4\u00a5 Board of Pharmacy regulations and guidelines for licensure.
- Oversee and monitor daily pharmacy operations, pharmacy-related investigational drugs, and trial components, ensuring compliance with all state / federal regulations and sponsor requirements.
- Accountable for management, oversight, and operations of all aspects within the pharmacy consistent with professional, ethical, and legal standards of proper pharmacy practice.
- Develops and implements patient and medication therapy management programs for investigational drugs.
- Automates the sponsor requirements for conducting investigational drug trials.
- Develops, implements, and reviews standard operating procedures for pharmacy and investigational drug services.
- Supervises and provides direction to technical/support staff.
- Provides input into performance appraisals of support staff.
- Collaboratively assist with medication and clinical operations of the infusion center.
- Manage and maintain inventory, workflow, pharmacy performance metrics, and the quality assurance tracking program.
- Ensure that billing & remittance documents are completed accurately and in a timely manner.
- Delegates work assignments and checks work orders filled by technicians.
- Monitors pharmacy activities on a daily basis to ensure adherence to study protocols and dispensing procedures of controlled drugs in accordance with federal and state regulations..
- Ensure confidentiality of patient information and their records, and destruction of relevant documentation that contains patient information.
- Attends and contributes to interdisciplinary team meetings relating to clinical investigational drug trials.
- Participates in the development of software programs designed to facilitate management of clinical investigational drug trials.
- Collects and documents workload measurement statistics; provides other data, as required.
- Collaborates in the identification and development of revenue-generating opportunities, as deemed appropriate.
Clinical Investigational Drug Trials
- Maintains responsibility for clinical investigational drug trials.
- Reviews protocols for University of Hawai\u00c4\u00a5 Cancer Center clinical investigational drug trials, as required.
- Liaises with principal investigators and/or trial coordinators/research assistants to establish the pharmacy’s role, determine fee schedules, and implement dispensing, compounding, and billing procedures.
- Communicates with and trains staff anticipated to participate in any aspect of the clinical investigational drug trial.
- Maintains a pharmacy electronic binder which contains a study summary, protocol, dispensing procedures, completed samples of required paperwork, dispensing checklist, fee schedule, billing procedures, and any other relevant materials for each investigational trial.
- Maintains and coordinates the distribution of an up-to-date list of clinical investigational drug trials, as scheduled.
- Maintains responsibility for the management of the inventory for clinical investigational drug trials; orders, replaces, and returns study materials, as required.
- Communicates any concerns regarding ethical issues or deviation from established University of Hawai\u00c4\u00a5 Cancer Center policies & procedures to the pharmacist participating on the University of Hawai\u00c4\u00a5 Cancer Center Ethics Committee.
- Assists in ensuring the participation of the pharmacy department in all clinical trials that involve drugs.
Education and Communication
- Orientates staff on the pharmacy’s role in clinical investigational drug trials.
- Promotes staff professional development; participates as an active member on committees; attends and/or presents at educational rounds, journal club, etc.
- Participates in the orientation and training of new employees and pharmacy residents, as required.
- Provides drug information to physicians, nurses, and other health care professionals, as related to clinical investigational trial drugs.
- Facilitates rapport between the University of Hawai\u00c4\u00a5 Cancer Center, principal investigators, clinical trial coordinators, research assistants, and trial sponsors.
- Consults with other pharmacy personnel to obtain information/expertise in support of the investigational drug trials, as required.
- Effectively communicates with colleagues and allied health professionals.
- Liaises with external agencies/organizations, as required.
- Contributes information about clinical investigational drug trials to the pharmacy newsletter.
- Complies with all legal requirements and company policies.
- Performs all other duties as assigned.
QUALIFICATION REQUIREMENTS
Education/Training
Minimum:
- PharmD from an accredited college or university.
- Completion of an accredited pharmacy postgraduate training program (PGY-1 and/or PGY-2 residency program).
- Board of Pharmaceutical Specialties certification in Investigational Drug Management, or 5 years of investigational drug experience
- Current and valid license with the State of Hawaii as a Pharmacist
- Current BLS/CPR Certification
- Within 30 days of hire, complete Collaborative Institutional Training Initiative (CITI) modules as assigned by the University of Hawai\u2019i Cancer Center administration.
Preferred:
- Advanced Cardiac Life Support (ACLS) - American Heart Association (AHA) certification as necessary.
- Pediatric Advanced Life Support (PALS) and/or Neonatal Resuscitation Program (NRP) certification as necessary.
- Completion of the American Society of Health-System Pharmacists (ASHP) Investigational Drug Service Certificate or equivalent
Experience
Minimum:
- Three years managing staff in a Pharmacy of Healthcare environment.
Minimum:
- Knowledge of state medical information release procedures and laws.
- Knowledge of HIPAA rules, regulations, and compliance.
- Knowledge of OSHA regulations for bloodborne pathogens.
BENEFITS
- Generous time off benefits
- 100% employee health and dental coverage and vision
- Flexible spending plan
- Retirement plan with up to 3% dollar-for-dollar company matching contributions
- Employee assistance program (EAP)
- Pet Insurance, Prepaid legal with competitive rates