Enhances the quality of care through preparation and dispensing of investigational medications. Investigational drug service pharmacists are responsible for protocol review, drug distribution, financial reimbursement, staff education, and training/continuing education as it relates to active investigational studies conducted at Our Lady of the Lake hospital and affiliated Clinics. The investigational drug service pharmacist also serves as the pharmacy liaison between the Pharmacy Department and various entities involved with Clinical Research. The Investigational Drug Service provides care to neonatal, pediatric, adolescent, adult, and geriatric populations.

• Quality and Compliance
• Reviews investigational protocols and determines the appropriate resources and materials to satisfy the study requirements.
• Provides randomization, blinding, and other activities as required by the study requirements.
• Prepares itemized budgets for investigational studies and requiring pharmacy participation.
• Develops procedures for preparation, dispensing, and distribution of investigational study drugs.
• Meets with investigators, study monitors, and others to coordinate study logistics.
• Establishes and maintains standards which assure the quality, proper storage and disposal, and safe use of all investigational agents and related supplies.
• Maintains and reports investigational service activity summaries.
• Leadership
• Responsible for development and administration of staff training programs regarding investigational drug procedures.
• Responsible for and assists with developing and implementing productivity monitors for the investigational drug service.
• Responsible for and assists with audits of inventory, drug dispensing records, and files by investigators and study sponsors.
• Responsible for overall guidance and direction to exceed compliance with regulatory bodies and/or specific protocols (e.g. JCAHO, ASHP, NIH, etc).
• Responsible for Quality Assurance Audits of all protocols managed by the IDS and Clinics affiliated with the Hospital.
• Collaboration and Partnership
• Assists in establishing and maintaining a liaison relationship with the IRB, Office of Research, Principal Investigators, Study Sponsors, and the Pharmacy Department.
• Assists in establishing and maintaining adequate and easily retrievable record keeping systems for protocols, study subjects, drug inventory, manufacturing, and dispensing of investigational drugs.
• Assists with both student and resident programs and their application to investigational drug services.
• Other Duties As Assigned
• Able to react to change productively and to handle other tasks as assigned.
• 5 years of hospital experience (clinical research experience preferred) Experience with unit dose drug distribution, chemotherapy, and IV admixutres.
• Doctor of Pharmacy or Bachelor of Pharmacy
• Licensed as a Pharmacist in the State of Louisiana

• Quality and Compliance
• Reviews investigational protocols and determines the appropriate resources and materials to satisfy the study requirements.
• Provides randomization, blinding, and other activities as required by the study requirements.
• Prepares itemized budgets for investigational studies and requiring pharmacy participation.
• Develops procedures for preparation, dispensing, and distribution of investigational study drugs.
• Meets with investigators, study monitors, and others to coordinate study logistics.
• Establishes and maintains standards which assure the quality, proper storage and disposal, and safe use of all investigational agents and related supplies.
• Maintains and reports investigational service activity summaries.
• Leadership
• Responsible for development and administration of staff training programs regarding investigational drug procedures.
• Responsible for and assists with developing and implementing productivity monitors for the investigational drug service.
• Responsible for and assists with audits of inventory, drug dispensing records, and files by investigators and study sponsors.
• Responsible for overall guidance and direction to exceed compliance with regulatory bodies and/or specific protocols (e.g. JCAHO, ASHP, NIH, etc).
• Responsible for Quality Assurance Audits of all protocols managed by the IDS and Clinics affiliated with the Hospital.
• Collaboration and Partnership
• Assists in establishing and maintaining a liaison relationship with the IRB, Office of Research, Principal Investigators, Study Sponsors, and the Pharmacy Department.
• Assists in establishing and maintaining adequate and easily retrievable record keeping systems for protocols, study subjects, drug inventory, manufacturing, and dispensing of investigational drugs.
• Assists with both student and resident programs and their application to investigational drug services.
• Other Duties As Assigned
• Able to react to change productively and to handle other tasks as assigned.
• 5 years of hospital experience (clinical research experience preferred) Experience with unit dose drug distribution, chemotherapy, and IV admixutres.
• Doctor of Pharmacy or Bachelor of Pharmacy
• Licensed as a Pharmacist in the State of Louisian