SUMMARY

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.

CORE JOB FUNCTIONS

• 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.

CORE QUALIFICATIONS

Education:

Pharm.D. degree

Certification and Licensing:

Pharmacist FL

Experience:

Minimum 1 year of relevant experience

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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

Job Status:

Employee Type: