Clinical Research Pharmacist

Core Job Functions

• Contributes to the research of investigational medicines and evaluates pharmaceutical care and services provided to human subjects participating in clinical trials.
• Functions as key therapeutic consultant and liaison among investigators, study team, nursing and the Investigational Drug Services (IDS) Pharmacy in directing and interpreting the appropriate use of investigational products (IP).
• Aids in design and implementation of the medication information section of clinical drug protocols.
• Aids investigators in prescribing investigational drug products, and other medications for subjects participating in clinical research studies.
• Edits all relevant research and pharmacy staff on investigational agents, drug protocols, IP administration and handling, and related clinical monitoring.
• Participates in clinical and research performance improvement programs and scientific review committees, as assigned.
• Reviews adverse drug reaction follow-ups, disease state management, pharmacokinetic and lab result evaluations, drug-drug and drug-food interactions, contraindications, inappropriate therapeutic regimens, and other pharmaceutical services.
• Provides medication counseling and assesses medication regimen adherence for patients receiving investigational medications.
• Reports unanticipated problems, adverse events, and clinical protocol deviations.
• Provides recommendations on supportive care to meet institutional guidelines and provide consistency within and across investigational studies.
• Aids in marketing research activities to aid in new product development.
• Serves as a resource to the public, healthcare professionals, and investigators in the development of investigator-initiated studies, including preparation of pharmacy manuals.
• Develops IDS Pharmacy policies and procedures.
• Maintains professional competency sufficient to meet the clinical needs of the IDS department, human subjects research office, and the University.
• Collects and documents workload measurement statistics; provides other data, as required.
• Completes reports including incident reports, adverse drug reaction reports, corrective action plans, etc.
• Oversees and instructs pharmacy learners (pharmacy students and residents) as it relates to clinical research pharmaceutical services.

Core Qualifications

• Pharm.D. degree
• Pharmacist certification and licensing
• Minimum 1 year of relevant experience