Job DescriptionThe Assistant Pharmacy Manager (APM) serves a vital role within the Clinical Investigational Research Pharmacy (CIRP) and participates in all aspects of investigational pharmacy operations. This position collaborates closely with the Pharmacy Manager to ensure the safe, compliant, and efficient handling of investigational products used in clinical research studies.
The APM applies advanced knowledge of pharmacology, pharmacokinetics, pathophysiology, and therapeutics to translate clinical research protocols into operational pharmacy procedures. Responsibilities include preparation, dispensing, accountability, storage, monitoring, and documentation of investigational products, including sterile and non-sterile formulations.
The APM supports regulatory compliance efforts by maintaining adherence to federal and state regulations, Good Clinical Practice (GCP) standards, sponsor requirements, institutional policies, and professional licensure requirements. The position assists with study start-up activities, monitoring visits, audits, quality assurance initiatives, and educational programs for pharmacy learners.
This is a professional position requiring licensure as a pharmacist in the State of Florida.
This is an in-office position based at the USF Health Morsani Center for Advanced Healthcare on the Tampa campus.ResponsibilitiesClinical Research Pharmacy Operations- Reviews clinical research protocols, pharmacy manuals, and study-specific requirements to develop investigational drug management procedures.
- Collaborates with Principal Investigators, Clinical Research Coordinators, sponsors, monitors, and CIRP staff to implement study-specific pharmacy operations.
- Prepares, compounds, dispenses, and accounts for investigational products in accordance with study protocols and applicable regulations.
- Maintains accurate investigational product records, accountability logs, temperature monitoring records, and study documentation.
- Orders investigational products and study-related supplies and coordinates receipt, storage, return, transfer, or destruction activities.
Regulatory Compliance and Quality Assurance - Ensures compliance with FDA regulations, DEA requirements, Good Clinical Practice (GCP), institutional policies, and study sponsor requirements.
- Assists in maintaining pharmacy licenses, permits, registrations, and regulatory documentation.
- Participates in quality assurance and continuous quality improvement initiatives.
- Supports audit readiness and prepares for sponsor monitoring visits, inspections, and regulatory reviews.
- Maintains all required records related to legend drugs, controlled substances, investigational products, and sterile compounding activities.
Sterile Compounding and Pharmacy Practice - Performs sterile and non-sterile compounding activities in accordance with USP and applicable regulations.
- Supports compliance with USP standards related to handling hazardous drugs.
- Maintains competency in aseptic technique, environmental monitoring, and quality assurance procedures.
- Ensures proper handling, storage, and dispensing of investigational products.
- Financial and Administrative Support
- Assists with preparation of study budgets, service quotes, billing activities, and invoice review.
- Participates in periodic evaluation of billing methodologies to ensure appropriate cost recovery and service pricing.
- Supports efforts to ensure timely invoicing and payment collection for pharmacy services.
Program Development and Education - Assists with development, implementation, revision, and maintenance of CIRP policies and standard operating procedures.
- Participates in site initiation visits and study activation activities.
- Supports expansion of investigational pharmacy services within the USF clinical research community.
- Precepts Doctor of Pharmacy students, pharmacy residents, and other learners as opportunities arise.
- Participates in professional development and educational activities relevant to clinical research pharmacy practice.
Other Duties - Provides operational coverage in collaboration with the Pharmacy Manager to ensure continuity of pharmacy services.
- Performs additional duties as assigned.
QualificationsMinimum Qualifications Licensure as a Pharmacist in accordance with Chapter 465, Florida Statutes.
One (1) year of pharmacist experience.
Preferred Qualifications Doctor of Pharmacy (PharmD) degree.
Experience in investigational drug services or clinical research pharmacy.
Experience with sterile compounding and aseptic technique in accordance with USP .
Knowledge of USP requirements and Good Clinical Practice (GCP) guidelines.
Experience with Vestigo® or other clinical research management software systems.
Proficiency with Microsoft Office Suite applications.
Experience working with investigational products in support of clinical trials.
Required Knowledge, Skills, and Abilities Excellent written, verbal, and interpersonal communication skills.
Strong organizational and problem-solving abilities.
Knowledge of clinical research processes and investigational product management.
Knowledge of federal, state, and institutional regulations governing clinical research.
Ability to interpret research protocols and implement study-specific pharmacy procedures.
Ability to manage multiple studies and competing priorities while maintaining accuracy and regulatory compliance.
Ability to work collaboratively with investigators, study coordinators, sponsors, monitors, and regulatory personnel.
Special Requirements Active Florida Pharmacist License in good standing.
Ability to maintain all required professional credentials and certifications.
Ability to maintain competency in investigational drug services and sterile compounding practices.
Compliance with all institutional, regulatory, and sponsor-specific training requirements.
