Investigational Pharmacist

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Responsible for implementing hospital and/or service line goals within the area. Performs other duties as assigned.

GENERAL DUTIES

• Performing day-to-day dispensing and accountability activities with regard to IRB-approved clinical trials.
• Establishing internal policies and procedures for developing and maintaining an Investigational Drug management system, which includes technical procedures for product ordering, adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects or researchers, and disposition of Investigational Medications (including documentation thereof).
• Consulting with University Medical Center New Orleans Research Staff to support research during the planning phase of investigator-initiated and sponsored clinical trials research, including but not limited to: (a) serving as a resource to Research Staff for issues of protocol budgeting, pharmacy reimbursement and patient flow logistics; (b) serving as a resource to Research Staff for issues of pharmacy relations with sponsors; and (c) serving as a resource to the IRB.
• Maintain a system for the inventory, distribution and dispensing of medications used in IRB-approved clinic trial research conducted under the auspices of University Medical Center New Orleans’s IRB. This includes receiving, accountability, inventorying, and returning/destroying all medications furnished under an IRB-approved protocol.
• For clinical trials where the PI controls the Investigational Drug at UMC, as approved by the IRB pursuant to a project-specific management plan, consult with the PI and Research Staff to ensure compliance with protocol and regulatory specifications for dispensing and, as requested by the IRB, to conduct audits of dispensing activity to the extent that such dispensing occurs through an IRB-approved management plan.
• Integrate scheduling of research therapy into standard treatment regimens for IRB-approved clinical trials, as appropriate.
• Maintain an archive of current and previous research protocols, manuals of procedures, and research informed consent and prescriptions for subjects at UMC.
• Prepare protocol-mandated records and reports on drug utilization and inventory.
• Participate in all site visits and audits at UMC as required by the FDA, OHRP, sponsors, regulatory or credentialing bodies.
• Prepare industry- or government-supplied pharmaceuticals (including medications where a UMC employee holds the IND for the Drug being tested) for administration to subjects at UMC per a University Medical Center New Orleans IRB-approved protocol.
• Obtain copies of adverse drug reactions documented and supplied by investigators or staff for subjects/patients receiving sponsor-supplied Investigational Drug or where a UMC employee holds the IND for the Drug being tested.
• Ensures adequate staff coverage for assigned department areas according to projected patient load and established budget.
• Monitors the day-to-day operations of assigned department staff, reacting effectively and efficiently to unplanned circumstances, demands and challenges facing the department to ensure consistent quality of service.
• Demonstrates expertise in hospital and department processes and keeps staff updated by remaining current with hospital and department guidelines, federal, state, regulatory & other governing policies, procedures or guidelines.
• Coordinates the departmental staff performance and improvement process, including the preparation, analysis and submission of required reports.
• Updates and improves the department processes and workflows.
• Participates as requested on teams, committees, and special projects, both internal and external, relating to investigation services.
• Functions as a staff pharmacist as workload and personnel shortages require. 

EXPERIENCE QUALIFICATIONS

Minimum of 3 year’s post-graduate pharmacist experience in institutional pharmacy preferred; preferably 3 or more years of progressive responsibility. Experience in research-based activities preferred.

LICENSES AND CERTIFICATIONS

Louisiana licensed pharmacist or eligible.

WORK SHIFT:

Days (United States of America)

LCMC Health is a community. 

Our people make health happen. While our NOLA roots run deep, our branches are the vessels that carry our mission of bringing the best possible care to every person and parish in Louisiana and beyond and put a little more heart and soul into healthcare along the way. Celebrating authenticity, originality, equity, inclusion and a little “come on in” attitude is the foundation of LCMC Health’s culture of everyday extraordi