Pharmacist – Investigational Drug Specialist

SUMMARY:

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. 

ESSENTIAL FUNCTIONS:

• Develop and implement policies, procedures, and best practices for investigational drug management in compliance with all applicable regulatory agencies including but not limited to FDA, DEA, ICH-GCP, USP and institutional guidelines.
• 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 when needed.
• Contribute to regulatory submissions, including IRB applications for spINDs and EAPS
• Submits IBC applications.
• Manage investigational products including procurement, receipt, storage, preparation, dispensing, accountability, disposal, chain of custody and documentation per study protocol and regulatory requirements.
• Develop pharmacy operations plans, applicable department workflows, blinding procedures, and emergency unblinding procedures for clinical trials.
• Participate in protocol review committees, site initiation visits, and study feasibility.
• Implement and maintain electronic systems (ie: Vestigo) 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 that meets FDA/GCP requirements for pharmacy personnel to conduct IP related trial activity.
• Collaborate with study sponsors, principal investigators, research coordinators, and clinical teams to ensure safe and efficient investigational drug management.
• Conduct a research or quality improvement projects in areas related to investigational drug services or clinical research pharmacy and identify opportunities for process improvement and efficiency.
• 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 prior to subject enrollment for protocol specific medication inclusion and exclusion criteria, concomitant meds, cautionary meds, and medication washouts.
• 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 to support patient safety and study integrity.
• Collaborate with sponsors, CROs, and monitors throughout the study life cycle (initiation, monitoring, close-out)
• Collaborate with departmental leaders on standard of care operations to be complaint with trials when standard of care medications falls within the scope of a trial.
• Provide education to pharmacy interns, students and PGY1 residents.
• Participate in quality improvement committees as assigned.
• Perform related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION: Doctor of Pharmacy degree from an AACP-accredited College of Pharmacy or bachelor’s degree from an AACP-accredited College of Pharmacy.   

EXPERIENCE: 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. Previous oncology, investigational drug service and pharmacy residency preceptor experience preferred. Previous working knowledge of GCP is preferred.

LICENSURE OR CERTIFICATION: Arizona pharmacist license upon hire. CITI training is required. 

KNOWLEDGE, SKILLS, AND ABILITIES: 

·         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, including the ability to document processes clearly, contribute to scholarly work, and communicate effectively with investigators, sponsors, and interdisciplinary team members.

·         Demonstrated ability to work both independently and collaboratively, showing initiative, accountability, and adaptability within a developing research environment.

·         Attention to detail and commitment to data integrity, particularly in maintaining investigational drug accountability records, reviewing protocols, and ensuring compliance with Good Clinical Practice (GCP) guidelines.

·         Capacity to manage multiple projects or studies simultaneously, prioritizing tasks effectively while meeting deadlines and regulatory requirements.

·         Critical thinking and problem-solving skills to assess protocol feasibility, address logistical challenges, and contribute to quality assurance and process improvement initiatives.

·         Interest in academic scholarship and professional development, including mentoring pharmacy students, participating in educational activities, and engaging in research suitable for publication or presentation.

·         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 or complaints from employees, patients and/or their representatives, and the public.

·         Ability to apply advanced mathematical concepts such as exponents or logarithms.

·         Ability to apply mathematical operations to such tasks as frequency distribution, single or multiple regressions, determination of test reliability and validity, correlation techniques, sampling theory and factor analysis.

·         Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

·         Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.).

·         Ability to deal with a variety of abstract and concrete variables.