Clinical Trials Pharmacist

University Health Partners of Hawaii•Honolulu, HI

17h

About The Position

As an integral member of the University of Hawaiʻi Cancer Center, the Clinical Trials Pharmacist performs responsibilities that enhance the departmentʻs reputation and service orientation. Duties include activities required for a pharmacist in charge as defined under board of pharmacy requirements of Hawaiʻi; 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.

Requirements

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’i Cancer Center administration.
Three years managing staff in a Pharmacy of Healthcare environment.
Knowledge of state medical information release procedures and laws.
Knowledge of HIPAA rules, regulations, and compliance.
Knowledge of OSHA regulations for bloodborne pathogens.

Nice To Haves

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

Responsibilities

Ensures compliance with the State of Hawaiʻi 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..
Provides accurate, efficient medication dispensing.
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.
Completes reports, including incident reports, adverse drug reaction reports, etc.
Collaborates in the identification and development of revenue-generating opportunities, as deemed appropriate.
Maintains responsibility for clinical investigational drug trials.
Reviews protocols for University of Hawaiʻi 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 Hawaiʻi Cancer Center policies & procedures to the pharmacist participating on the University of Hawaiʻi Cancer Center Ethics Committee.
Assists in ensuring the participation of the pharmacy department in all clinical trials that involve drugs.
Maintains professional development.
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 Hawaiʻi 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.