Clinical Research Pharmacist

ECN Operating • Sun City, AZ

8h

About The Position

The Clinical Research Pharmacist (PRN) is responsible for managing and coordinating the investigational product (IP) operations for clinical research studies requiring complex preparation or aseptic technique. This role ensures that pharmacy research activities are conducted in compliance with regulatory requirements, study protocols, Good Clinical Practice (GCP) guidelines, and USP standards. The Pharmacist works closely with the Site Director, investigators, and blinded/unblinded study staff to support high-quality, safe, and ethical research.

Requirements

• 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 12 years of hospital or compounding pharmacy experience required.
• USP Proficiency: Demonstrated knowledge of sterile compounding and aseptic technique.
• IVRS/IWRS: Familiarity with randomization portals and inventory management systems.
• Mastery of Body Surface Area (BSA), weight-based dosing, and complex dilution factors.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills.
• Familiarity with HIPAA and human subject protection regulations.
• Ability to stand, walk, sit, use hands, and reach with arms.
• Ability to lift up to 25 pounds occasionally.
• Ability to wear personal protective equipment (PPE) for extended periods while working in the compounding hood.

Nice To Haves

• Prior Clinical Research experience (handling IP, blinding, and protocol specific compounding)
• 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 in strict accordance with the study protocol and Pharmacy Manual.
• Sterile Compounding (USP ): Maintain a sterile environment for preparing sterile compounds and apply rigorous aseptic techniques to prevent contamination and ensure patient safety.
• Protocol & Blinding Adherence: Execute the site-specific Blinding Plan for randomized trials. Ensure that unblinded IP information (e.g., assignment, preparation details) is handled strictly in accordance with protocol to prevent unblinding of study staff or participants.
• IVRS/IWRS Management: Navigate web-based Interactive Response Technology (IRT) systems for subject randomization, kit assignment, and inventory management.
• Accountability & Documentation: Maintain accurate IP Accountability Logs to ensure 100% traceability of all dispensed, returned, and destroyed product.
• Inventory Management: Oversee receipt and storage across various conditions (Ambient, 2-8C, -20C, -80C). Monitor continuous temperature logs and lead the resolution/reporting of temperature excursions.
• Monitor Visits: Meet with Clinical Research Associates (CRAs) during monitoring visits to review pharmacy binders, drug accountability records, and resolve queries.
• Support Audit Readiness: Maintain and organize pharmacy regulatory binders and study documentation in compliance with FDA, GCP, and Sponsor requirements.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree