Research Pharmacist

California Clinical Trials Medical Group is currently looking for a Research Pharmacist to be part of an energetic and experienced team of researchers.

The primary responsibilities of the Research Pharmacist are to ensure accurate investigational drug dispensation and accountability for all protocols conducted at the Glendale Adventist Medical Center (GAMC) facility; to coordinate medication management services for study participants; to adhere to all GAMC hospital pharmacy requirements; and to be the administrative liaison to the GAMC hospital pharmacy as the pharmacist responsible for the California Clinical Trials Medical Group (CCTMG) Satellite pharmacy.

Major Responsibilities
Including but not limited to the following and other duties as may be assigned:

Pharmacy:

•Under the clinical supervision of the Medical Director and administrative direction of the Director, Clinical Operations, oversees and manages Pharmacy Staff and drug preparation for all studies.

•Communicates and interacts with Sponsors directly on issues of drug shipment and dispensation.

•Tracks drug inventory and orders drug supply from Sponsor.

•Meets with Clinical Research Coordinator and/or Pharmacy Technician to review study medication dispensing procedures for each study.

•Directly dispenses study medication as necessary.

•Ensures proper blinding/randomization of study medication.

•Supervises preparation of labels and drug accountability forms. Performs accountability for Early Drug Development (EDD) studies.

•Ensures proper drug storage, drug accountability and record keeping (e.g., temperature logs, etc.) as well as proper transportation between facilities.

•Reviews all concomitant medications brought in by study participants for EDD studies.

•Coordinates dispensation of concomitant medications.

•Provides and/or oversees the provision of drug regimen review and medication management services for study participants admitted to GAMC.


Administrative:

•Serves as a liaison between CCTMG, the GAMC Pharmacy and the GAMC Director of Pharmacy.

•Ensures that the CCTMG Pharmacy meets all applicable requirements necessary to operate as a satellite pharmacy under the GAMC Inpatient Pharmacy license.

•Interacts with GAMC Pharmacy and other hospital administrators and staff to ensure CCT Pharmacy meets JCAHO requirements.

•Determines the necessity for the creation of departmental Clinical Operating Guidelines (COGs) to meet medication management and drug regiment review requirements of the hospital and JCAHO. Oversees and approves the review, revision, and/or retirement of COGs. Upon approval, oversees the training and implementation of departmental COGs and inter-departmental COGS.

•Manages all aspects of departmental performance improvement strategies including: identifies areas for improvement, develops an action plan in conjunction with all affected areas/staff, tracks results and reports results to Sr. Management.

•Maintains and updates knowledge of Good Clinical Practices (GCPs) and their proper application. Reinforces the use of GCPs as they apply departmentally through example and staff training.


Secondary Responsibilities
Scientific Affairs

•Acts as a Sub-Investigator on studies.

•Provides clinical and scientific monitoring.

•Assists VP, Director of Research and Sr. VP, Chief Scientific Officer in preparing abstracts, manuscripts, protocols and/or books for publication.

•Represents CCTMG through presentations and attendance at scientific meetings.

•Reviews and revises Informed Consent as necessary (i.e., based on new clinical investigator’s brochure, Serious Adverse Effects (SAE) reports).

•Reviews Institutional Review Board (IRB) documents including initial application, amendment application, progress reports and close out reports.

•Arranges and represents CCTMG at IRB meetings including hospital IRB meetings.

•Ensures proper reporting of adverse events to IRB and the Sponsor (or Sponsor Representative).

•Participates in the Regulatory Compliance meetings in such activities as reviewing new FDA guidelines, establishing timelines for IRB meetings, reviewing activities with the IRB and updating newly proposed studies.

•Meets with the CRCs prior to study initiation to review study medication pharmacology, key issues and plans for monitoring identified parameters.

•Performs Quality Assurance (QA) functions and signs off on study Flow Sheets when required.

•Serves as a resource for study protocol clarification and interpretation.


Miscellaneous

•Contacts primary medical doctors as needed to obtain study participant history, diagnosis or approval for participation in a study.

•Reviews concomitant medications for evaluating Inclusion/Exclusion criteria.

•Reviews all newly proposed study protocols and provides feasibility comments to appropriate department representatives.

•Other duties as assigned.


Qualifications:
Pharm.D. with 3 - 5 years experience in research and/or hospital environments.
Valid California Pharm.D. license.
Computer proficiency mandatory.
Travel is required.
Flexible schedule.

Competencies and Best Practice for High Performers:
Excellent clinical pharmacy knowledge.
Strong written and verbal communication skills and interpersonal skills.
Meticulous attention to detail.
Ability to multi-task.


TO APPLY:
Please submit your resume/CV.