The Investigational Drug Pharmacist plays a crucial role in the management and oversight of investigational drugs used in clinical research trials.
Ensures the safe and effective use of investigational medications and compliance with regulatory requirements.
Collaborates with research teams and monitors drug handling and storage.
Assists local sites with enrollment, randomization, blinding, logging, preparation, dispensing, delivery, accounting, and storage of investigational drugs.
Prepares and reviews documentation for Investigational New Drug (IND) applications and other regulatory submissions.
Conducts audits, site visits and inspections to ensure adherence to regulatory requirements.
Provides education and training to pharmacy staff and other healthcare professionals on new systems, practices, and research findings.