The Clinical Research Pharmacist 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). Assists in design and implementation of the medication information section of clinical drug protocols. Assists investigators in prescribing investigational drug products, and other medications for subjects participating in clinical research studies. Educates all relevant research and pharmacy staff on investigational agents, drug protocols, IP administration and handling, and related clinical monitoring. Actively participates in clinical and research performance improvement programs and scientific review committees, as assigned. Responsible for clinical drug protocol review, electronic medical record treatment plan / protocol build review, design of oncologic regiments, etc. 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. Participates in the reporting of 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. Assists in marketing research activities to aid in new product development. Ensures compliance with all applicable governmental and sponsor regulations, laws, and policies. Serves as a resource to the public, healthcare professionals, and investigators in the development of investigator-initiated studies, including preparation of pharmacy manuals. Assists with the development of 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. Adheres to University and unit-level policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities, as necessary. Core qualifications include Pharm.D. degree, Licensed as Florida Registered Pharmacist, and minimum 1 year of relevant experience. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
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