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Pharmacist – Investigational Drug Specialist is responsible for managing all pharmaceutical aspects of clinical research, ensuring compliance with protocols, GCP, IRB/FDA regulations and IPS handling. Responsibilities include: maintaining drug accountability, ensuring compliance with federal regulations, state board of pharmacy regulations, institutional policies and study protocols, serving as a liaison between the pharmacy department and investigators, sponsors, research staff and regulatory bodies, promoting the safe and ethical use of investigational drugs, collaboration with nursing and medical staff with medication chart reviews to assist in the optimization of medication therapy, providing oversight of clinical services in area of expertise and collecting and analyzing quality metrics within the oncology research specialty area. In addition, the Pharmacist – Investigational Drug Specialist is an active preceptor for PGY1 residents and pharmacy students and a clinical resource for pharmacy staff.
Job Responsibility:
Develop and implement policies, procedures, and best practices for investigational drug management
Prepare for and participate in audits, inspections, and monitoring visits
Ensure pharmacy adherence to IRB-approved protocols and sponsor requirements
Oversee documentation of adverse drug events and pharmacy related protocol deviations and CAPAs
Contribute to regulatory submissions
Manage investigational products including procurement, receipt, storage, preparation, dispensing, accountability, disposal, chain of custody and documentation
Develop pharmacy operations plans, applicable department workflows, blinding procedures, and emergency unblinding procedures
Participate in protocol review committees, site initiation visits, and study feasibility
Implement and maintain electronic systems for investigational drug tracking and accountability
Provide protocol build specifications, validation and amendment of drug protocols and IP products in the EMR system
Coordinate mapping between EMR, electronic drug accountability and CTMS systems for drug products
Establish and provide ongoing education and training to site pharmacy personnel
Collaborate with study sponsors, principal investigators, research coordinators, and clinical teams
Conduct a research or quality improvement projects
Attend site initiation visit and complete protocol specific training
Review and educate providers on Investigational Drug Brochures
Facilitate screening processes for specific studies to increase accrual
Reviews concomitant medications taken by research patients and advises providers
Develop and monitor IDS workload, budget, billing, and cost recovery processes
Develop a system to ensure medication reconciliation and provide subject specific medication consultation
Review lab values and consult protocols to verify orders are clinically appropriate prior to compounding/dispensing medications
Support order verification for investigational drugs
Communicate effectively with multidisciplinary teams
Collaborate with sponsors, CROs, and monitors throughout the study life cycle
Collaborate with departmental leaders on standard of care operations
Provide education to pharmacy interns, students and PGY1 residents
Participate in quality improvement committees as assigned
Perform related duties as assigned
Requirements:
Doctor of Pharmacy degree from an AACP-accredited College of Pharmacy or bachelor’s degree from an AACP-accredited College of Pharmacy
Five (5) years of clinical pharmacist experience or completion PGY1 residency with three (3) years of additional experience or PGY2 with one (1) additional year of experience
Arizona pharmacist license upon hire
CITI training is required
Strong foundational knowledge of pharmacy practice with a particular interest in clinical research, investigational drug management, and regulatory compliance in healthcare settings
Excellent written and verbal communication skills
Demonstrated ability to work both independently and collaboratively
Attention to detail and commitment to data integrity
Capacity to manage multiple projects or studies simultaneously
Critical thinking and problem-solving skills
Interest in academic scholarship and professional development
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to inquiries
Ability to apply advanced mathematical concepts
Ability to apply mathematical operations
Ability to apply principles of logical or scientific thinking
Ability to deal with nonverbal symbolism
Ability to deal with a variety of abstract and concrete variables
Nice to have:
Previous oncology, investigational drug service and pharmacy residency preceptor experience