About the Company
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. Mayo Clinic in Florida is a premier medical institution dedicated to pushing the boundaries of medical research and patient care. Join a team where innovation meets compassion, contributing to life-changing discoveries and improving health outcomes globally.
Job Description
We are seeking a highly motivated and detail-oriented Clinical Trial Pharmacy Assistant with a strong focus on research and laboratory support to join our dedicated team in Jacksonville, FL. In this critical role, you will be instrumental in the management and dispensing of investigational medicinal products (IMPs) for various clinical trials, ensuring strict adherence to study protocols, regulatory guidelines, and Good Clinical Practice (GCP). This position offers a unique opportunity to contribute directly to groundbreaking medical research within a world-renowned institution.
Key Responsibilities
- Manage the inventory, storage, and security of investigational medicinal products (IMPs) according to study protocols and institutional policies.
- Prepare, label, and dispense IMPs for study participants as prescribed by research investigators, ensuring accuracy and complete documentation.
- Perform drug accountability and reconciliation activities for assigned clinical trials, maintaining meticulous records.
- Assist with the preparation and packaging of IMPs for shipment to study sites or internal distribution, adhering to cold chain requirements where applicable.
- Support laboratory procedures involving IMPs, including aliquot preparation, sample handling, and data recording.
- Ensure all pharmacy activities are in compliance with federal regulations (e.g., FDA), institutional review board (IRB) requirements, and GCP/ICH guidelines.
- Collaborate effectively with clinical research coordinators, principal investigators, and other members of the research team.
- Participate in quality control activities, audits, and inspections related to investigational pharmacy services.
- Maintain a clean and organized work environment within the research pharmacy and laboratory areas.
- Provide training and guidance to new staff or students regarding investigational product handling and procedures.
Required Skills
- Pharmacy Technician Certification (CPhT) or equivalent licensure/registration.
- Minimum of 1 year of experience in a pharmacy setting, preferably in a hospital or clinical research environment.
- Strong understanding of pharmacy operations and pharmaceutical terminology.
- Demonstrated knowledge of Good Clinical Practice (GCP) and relevant regulatory requirements (e.g., FDA 21 CFR Part 312).
- Excellent attention to detail and accuracy in all tasks.
- Proficiency in inventory management and record-keeping.
- Strong organizational and time management skills.
- Ability to work independently and collaboratively within a multidisciplinary team.
- Effective written and verbal communication skills.
Preferred Qualifications
- Previous experience specifically in an investigational drug pharmacy or clinical trials.
- Experience with sterile compounding techniques.
- Associate's or Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Pharmaceutical Sciences).
- Familiarity with electronic health records (EHR) and clinical trial management systems (CTMS).
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- Generous paid time off (PTO) and holidays.
- 403(b) retirement plan with employer contributions.
- Tuition reimbursement and professional development opportunities.
- Life and disability insurance.
- Employee assistance program.
- Access to on-site wellness programs and facilities.
- Opportunity to work with cutting-edge research and world-renowned experts.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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