Description

Job Summary

Works as part of an interdisciplinary team and subject matter expert for the planning, developing, and maintaining investigational drug services across the health system including clinical research protocols, compassionate use, and expanded access protocols. Collaborates closely with the Research Institute and corresponding Institutional Review Board (IRB). Works effectively with a variety of stakeholders including the MCHRI team, investigators, and sponsors.

Minimum Job Requirements

• Doctor of Pharmacy required.
• Current Florida Pharmacist License required.
• Minimum of 2-5 years hospital experience.
• Previous experience with investigational studies and clinical research.
• CPR: Healthcare Provider

Qualifications

Essential Duties and Responsibilities

• Develops and maintains policies and procedures to define overall investigational drug services and study specific standard operating procedures.
• Assists Research Institute and investigators with study needs including randomization and drug blinding procedures.
• Participates in study feasibility review, initial site assessment, Institutional Review Board (IRB) process, study initiation, and ongoing study monitoring.
• Maintains a current fee schedule for research pharmacy services and works with Research Institute to develop study protocol specific pharmacy budgets.
• Plans, organizes, and supports research pharmacy operations including execution of clinical research protocols and adherence to good documentation practices.
• Provides education and serves as a subject matter expert to clinical research team regarding the use of investigational drugs.
• Develops and maintains a quality program regarding Research Pharmacy activities and submits reports.
• Represents the department in interactions with study-related personnel, administration, sponsors, state & federal regulatory agencies (e.g. FDA), and other regulatory agencies (e.g. AAHRPP).
• Collaborate with the Research Institute regarding management of study inventory including temperature monitoring and documentation.
• Maintains current information and data of all relevant areas of research pharmacy and clinical research.
• Responsible for enhancing information and data by attending seminars, regional and national meetings, as well as, specific study investigator meetings.
• Participates in special projects and committees as assigned and trains/precepts pharmacy technicians, pharmacists, pharmacy residents, and pharmacy students.

Knowledge/Skills/Abilities

• Phase I experience preferred.
• Hematology/Oncology experience preferred.
• Proficient in Microsoft Word, Excel, & Access.
• Team oriented and skilled communicator with demonstrated expertise in the clinical research and hospital settings.
• Ability to assess patient care conditions and evaluate patient response to medication therapy regimens.
• Ability to communicate and present information effectively in both oral and written form with all levels of hospital personnel and all patient groups.
• Ability to exercise independent judgment and decision making.
• Ability to operate equipment and pharmacy information systems (Electronic Health Record, Automated Dispensing Machines, e.g. Pyxis(r) and PC desktop systems).
• Ability to problem solve and think analytically.
• Ability to provide supervisory oversight for technical staff related to investigational medication preparation and dispensing.
• Ability to relate cooperatively and constructively with patients, co-workers, clinical, medical staff, and interdisciplinary clinical research teams.
• Knowledge of pharmacokinetic and pharmacotherapeutic properties of medications.

(EOE DFW)

10/13/15

Job :

Primary Location :

Department :

Job Status