PRN Clinical Research Pharmacist - Sterile IP Operations

ECN Operating LLC; San Jose (CA); On-site; USD 62,000 - 83,000; Full time

Job summary

ECN Operating LLC is seeking a Clinical Research Pharmacist (PRN) to manage IP operations for complex clinical studies with strict aseptic technique and regulatory compliance. The role interfaces with the Site Director, investigators, and study staff to support safe, ethical research.

Responsibilities include IP preparation, sterile compounding, adherence to blinding plans, IRT/IWRS management, IP accountability, and regulatory documentation.

Qualifications

• PharmD required and licensed to practice pharmacy.
• Current IATA certification for shipping dangerous goods (or willingness to obtain within 30 days).
• Minimum 1–2 years hospital or compounding pharmacy experience.

Responsibilities

• Prepare, compound, and dispense IV infusions, subcutaneous injections, and oral medications per protocol and Pharmacy Manual.
• Maintain sterile environment and aseptic technique for sterile compounding.
• Follow Blinding Plan for randomized trials and manage unblinded IP information per protocol.
• Navigate IRT/IWRS systems for subject randomization, kit assignment, and inventory.
• Maintain IP Accountability Logs for traceability of dispensed, returned, and destroyed product.
• Oversee storage across ambient, 2-8°C, -20°C, -80°C with temperature logging and deviation handling.
• Meet with CRAs during monitoring visits to review pharmacy binders and drug accountability.
• Maintain regulatory binders and documentation in compliance with FDA, GCP, and sponsor requirements.

Skills

USP proficiency

IVRS/IWRS

Dosing calculations (BSA/weight)

Attention to detail

Communication

HIPAA compliance

Education

Doctor of Pharmacy (PharmD)

Active Pharmacist license (state)

IATA certification for shipping dangerous goods

Tools

None

Job description

ECN Operating LLC is seeking a Clinical Research Pharmacist (PRN) to manage IP operations for complex clinical studies with strict aseptic technique and regulatory compliance. The role interfaces with the Site Director, investigators, and study staff to support safe, ethical research.

Responsibilities include IP preparation, sterile compounding, adherence to blinding plans, IRT/IWRS management, IP accountability, and regulatory documentation.