Assistant Pharmacy Manager

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 <797> and applicable regulations.
• Supports compliance with USP <800> 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.

Qualifications

Minimum 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 <797>.

Knowledge of USP <800> 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.

About Us

Working at USF

With approximately 16,000 employees, the University of South Florida is one of the largest employers in the Tampa Bay area. We are dedicated to cultivating a talented, engaged and driven workforce that strives to be bold. Employees excel in USF's rich academic environment, which fosters their development and advancement. In 2025, Forbes recognized USF as one of Florida's best large employers, ranked No. 1 among the state's 12 public universities. Our first-class benefits package includes medical, dental and life insurance plans, retirement plan options, employee and dependent tuition programs, generous leave, and hundreds of employee perks and discounts.

About USF

The University of South Florida is a top-ranked research university serving approximately 50,000 students from across the globe at campuses in Tampa, St. Petersburg, Sarasota-Manatee and USF Health. USF is recognized by U.S. News & World Report as a top 50 public university and the best value in Florida. U.S. News also ranks the USF Health Morsani College of Medicine as the No. 1 medical school in Florida and in the highest tier nationwide. USF is a member of the Association of American Universities (AAU), a group that includes only the top 3% of universities in the U.S. With an all-time high of $738 million in research funding in 2024 and as a top 20 public university for producing U.S. patents, USF uses innovation to transform lives and shape a better future. The university generates an annual economic impact of more than $6 billion. USF's Division I athletics teams compete in the American Athletic Conference. Learn more at www.usf.edu.

Compliance and Federal Notices

This position may be subject to a Level 1 or Level 2 criminal background check.

Applicants have rights under Federal Employment Laws:

The University of South Florida is an equal opportunity employer that does not discriminate against any employee or applicant for employment based on any characteristic protected by law. The University maintains programs for protected veterans and individuals with disabilities in accordance with all applicable federal and state laws.

Family and Medical Leave Act (FMLA)

Applicants for USF employment are entitled to request reasonable accommodation(s) in the application process. A request is to be made at least five (5) working days prior to the time the accommodation(s) is needed. Visit the Central Human Resources ADA Accommodations webpage for more information on requesting an accommodation during the application/interview process.

Equal Employment Opportunity

The University of South Florida is an equal opportunity employer that does not discriminate against any employee or applicant for employment based on any characteristic protected by law. The University maintains affirmative action programs for protected veterans and individuals with disabilities in accordance with all applicable federal and state laws. This job description does not constitute an employment contract.