Clinical Research Pharmacist

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

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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.

Key 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, 2-8°C, -20°C, -80°C). 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.

Qualifications:

Education

• 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).

Experience

• Minimum 1–2 years of hospital or compounding pharmacy experience required.
• Prior Clinical Research experience (handling IP, blinding, and protocol specific compounding) is highly preferred.
• Experience with USP sterile compounding standards and USP hazardous drug handling.

Skills

• 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.

Working Conditions

• Schedule: PRN (as needed). Shifts are driven by patient enrollment, randomization schedules, and infusion windows.
• Must be willing to travel to the site for scheduled dosing visits and monitoring visits.

Physical Requirements

• 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.

Pay

• $45-60/hr

Equal Opportunity Employer:

Elite Clinical Network is an equal opportunity employer and does not discriminate on the basis of race, color, religion, gender, gender identity, sexual orientation, national origin, disability, age, or veteran status.