Research Pharmacist

Key Accountabilities Oversee and manage Pharmacy Staff and drug preparation for all studies. Communicate and interact with Sponsors directly on issues of drug shipment and dispensation. Track drug inventory and orders drug supply from Sponsor. Meet with Clinical Research Coordinators (CRC) and/or Pharmacy Technicians to review study medication dispensing procedures for each study. Directly dispense study medication as necessary. Ensure proper blinding/randomization of study medication. Supervise preparation of labels and drug accountability forms. Perform accountability for studies. Ensure proper drug storage, drug accountability and record keeping (e.g., temperature logs, etc.) as well as proper transportation between facilities. Understand and utilize the Rees Scientific systems for the Pharmacy. Review all concomitant medication brought in by study participants. Coordinates dispensation of concomitant medications. Provide and/or oversee the provision of drug regimen review and medication management services for study participants admitted to GAMC. Serve as a liaison between CCTMG, the GAMC Pharmacy and the GAMC Director of Pharmacy. Ensure that the CCTMG Pharmacy meets all applicable requirements necessary to operate as a satellite pharmacy under the GAMC Inpatient Pharmacy license. Interact with GAMC Pharmacy and other hospital administrators and staff to ensure the CCTMG Pharmacy meets hospital requirements. Determine the necessity for the creation of departmental Clinical Operating Guidelines (COGs) to meet medication management and drug regiment review requirements of the hospital. Oversee and approve the review, revision, and/or retirement of COGs. Oversee the training and implementation of departmental COGs and inter-departmental COGS upon approval. Manage all aspects of departmental performance improvement strategies including: identifying areas for improvement, developing an action plan in conjunction with all affected areas/staff, tracking results and reporting results to Director, Cliniical Operations. Maintain and update knowledge of Good Clinical Practices (GCPs) and their proper application. Reinforce the use of GCPs as they apply departmentally through example and staff training. Act as a Sub-Investigator on studies. Provide clinical and scientific monitoring. Assist in preparing abstracts, manuscripts, protocols and/or books for publication. Represent CCTMG through presentations and attendance at scientific meetings. Review 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. Arrange and represent CCT at IRB meetings including hospital IRB meetings. Ensure proper reporting of adverse events to IRB and the Sponsor (or Sponsor Representative). Participate 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. Meet with the CRCs prior to study initiation to review study medication pharmacology, key issues and plans for monitoring identified parameters. Perform Quality Assurance (QA) functions and signs off on study Flow Sheets when required. Serve as a resource for study protocol clarification and interpretation. Other duties as assigned. QualificationsSkills Excellent clinical pharmacy knowledge. Strong written and verbal communication skills and interpersonal skills. Meticulous attention to detail. Ability to multi-task. Computer proficiency mandatory. Travel is required. Flexible schedule.

Education BA, BS, or equivalent and Pharm.D. required. Valid California Pharm.D. license.

Language Skills 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.