Aseptic IP Clinical Pharmacist — Research-Driven

ECN Operating LLC; Sun City West (AZ); On-site; USD 83,000 - 131,000; Full time

Job summary

Elite Clinical Network in the United States seeks a Clinical Research Pharmacist PRN to manage investigational product operations for complex trials, ensuring compliance with GCP, FDA, and USP standards. The role collaborates with the Site Director, investigators, and study staff to support safe and ethical research.

Responsibilities include IP preparation and dispensing, sterile compounding, adherence to blinding plans, IP logging, and IRB/audit readiness, with travel to sites for dosing and

Qualifications

• Doctor of Pharmacy or PharmD degree.
• 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 12 years of hospital or compounding pharmacy experience.
• Prior Clinical Research experience handling IP blinding and protocol specific compounding is preferred.
• Experience with USP sterile compounding standards and USP hazardous drug handling.

Responsibilities

• Investigational Product (IP) Preparation and dispensing of IV infusions, subcutaneous injections, and oral meds per study protocol and Pharmacy Manual.
• Maintain sterile environment and aseptic technique for IP preparation.
• Adhere to Blinding plans and protect IP information to prevent unblinding.
• Manage IVRS/IWRS systems for subject randomization, kit assignment, and inventory.
• Maintain IP Accountability Logs ensuring traceability of all dispensed, returned, and destroyed product.
• Oversee IP inventory across ambient and controlled temperatures and monitor temperature excursions.
• Support monitoring visits and audits by CRAs; prepare pharmacy binders and regulatory documentation.

Skills

Pharmacist license

IATA

Clinical research experience

USP standards

HIPAA

Detail oriented

Communication

Education

Doctor of Pharmacy (PharmD)

Job description

Elite Clinical Network in the United States seeks a Clinical Research Pharmacist PRN to manage investigational product operations for complex trials, ensuring compliance with GCP, FDA, and USP standards. The role collaborates with the Site Director, investigators, and study staff to support safe and ethical research.

Responsibilities include IP preparation and dispensing, sterile compounding, adherence to blinding plans, IP logging, and IRB/audit readiness, with travel to sites for dosing and