PRN Clinical Research Pharmacist - Sterile Compounding & IP

ECN Clinical; San Diego (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

ECN Clinical is seeking a Clinical Research Pharmacist to manage investigational product operations for studies requiring aseptic technique. You will ensure compliance with FDA, GCP, and USP standards while collaborating with the Site Director, investigators, and study staff.

The role involves IV infusions, sterile compounding, IP accountability, and use of IRT systems, with travel to sites for dosing and monitoring visits.

Qualifications

• PharmD degree required; active pharmacist license in the state of practice.
• IATA certification for shipping dangerous goods (or willingness to obtain within 30 days).
• Experience with USP sterile compounding standards and hazardous drug handling.

Responsibilities

• Prepare, compound, and dispense IV infusions, subcutaneous injections, and oral meds per protocol.
• Maintain sterile environment and aseptic technique for sterile compounds.
• Adhere to Blinding Plan to prevent unblinding during randomized trials.
• Navigate IRT systems for subject randomization, kit assignment, and inventory.
• Maintain IP accountability logs for traceability and regulatory compliance.
• Oversee IP receipt/storage across ambient and cold conditions; monitor temp logs.
• Meet CRAs during monitoring visits to review pharmacy binders and drug records.
• Support audit readiness by organizing regulatory binders and study docs.

Skills

USP Proficiency

IVRS/IWRS

BSA and weight-based dosing

Complex dilution factors

Attention to detail

Communication skills

HIPAA familiarity

Education

Doctor of Pharmacy (PharmD)

Active pharmacist license

IATA certification for shipping dangerous goods

Job description

ECN Clinical is seeking a Clinical Research Pharmacist to manage investigational product operations for studies requiring aseptic technique. You will ensure compliance with FDA, GCP, and USP standards while collaborating with the Site Director, investigators, and study staff.

The role involves IV infusions, sterile compounding, IP accountability, and use of IRT systems, with travel to sites for dosing and monitoring visits.