Clinical Research Pharmacist: IP Prep & Sterile Compounding

Elite Clinical Network; San Jose (CA); On-site; USD 214,906,000 - 243,560,000; Full time

Job summary

Elite Clinical Network seeks a Clinical Research Pharmacist (PRN) to manage investigational product operations for complex studies, ensuring compliance with FDA, GCP, and USP standards. You will work with Site Director, investigators, and study staff to support safe, ethical research.

The role requires handling IP, blinding, and sterile compounding, with travel to sites for dosing and monitoring visits. Pharmacist license and PharmD are essential.

Qualifications

• Doctor of Pharmacy (PharmD) degree required.
• Active, unrestricted Pharmacist license in the state of practice.
• Current IATA Certification for shipping dangerous goods (or willingness to obtain within 30 days of hire).
• Minimum 1–2 years of hospital or compounding pharmacy experience required.
• Prior Clinical Research experience preferred.
• Experience with USP sterile compounding standards and USP hazardous drug handling.

Responsibilities

• Investigational Product (IP) Preparation: prepare, compound, and dispense IV infusions, subcutaneous injections, and oral medications per protocol.
• Sterile Compounding: maintain sterile environment and aseptic technique to ensure patient safety.
• Protocol & Blinding Adherence: follow blinded trial plans and protect unblinded IP information.
• IVRS/IWRS Management: navigate IRT systems for randomization and inventory management.
• Accountability & Documentation: maintain IP accountability logs for traceability of dispensed, returned, and destroyed product.
• Inventory Management: manage receipt/storage across ambient, 2–8°C, -20°C, -80°C, monitor temperature logs.

Skills

USP sterile compounding

Aseptic technique

IVRS/IWRS familiarity

BSA and weight-based dosing

Attention to detail

Communication skills

HIPAA compliance

Education

PharmD

Active Pharmacist license

IATA certification

Tools

IVRS/IWRS systems

Job description

Elite Clinical Network seeks a Clinical Research Pharmacist (PRN) to manage investigational product operations for complex studies, ensuring compliance with FDA, GCP, and USP standards. You will work with Site Director, investigators, and study staff to support safe, ethical research.

The role requires handling IP, blinding, and sterile compounding, with travel to sites for dosing and monitoring visits. Pharmacist license and PharmD are essential.