Clinical Trial Operations Opportunities at PAREXEL
Clinical Trial Operations
Research PharmacistJob ID 49603BR Glendale, California
• 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 Coordinators (CRC) and/or Pharmacy Technicians 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 studies.
• Ensures proper drug storage, drug accountability and record keeping (e.g., temperature logs, etc.) as well as proper transportation between facilities.
• Understands and utilizes the Rees Scientific systems for the Pharmacy.
• Reviews all concomitant medications brought in by study participants.
• 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.
• 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 the CCTMG Pharmacy meets hospital 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.
• 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.
• Assists 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 CCT 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.
• 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.
• Excellent clinical pharmacy knowledge.
• Strong written and verbal communication skills and interpersonal skills.
• Meticulous attention to detail.
• Ability to multi-task.
• Computer proficiency mandatory
• Flexible schedule
• BA, BS, or equivalent and Pharm.D. required
• Valid California Pharm.D. license.
• Fluent English
Minimum Work Experience
• 2-5 years experience in clinical research or hospital environments preferred
EEO DisclaimerPAREXEL is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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