Clinical Research Pharmacist

Elite Clinical Network; San Jose (CA); On-site; USD 214,906,000 - 243,560,000; Full time

Job summary

Elite Clinical Network seeks a Clinical Research Pharmacist (PRN) to manage investigational product operations for complex studies, ensuring compliance with FDA, GCP, and USP standards. You will work with Site Director, investigators, and study staff to support safe, ethical research.

The role requires handling IP, blinding, and sterile compounding, with travel to sites for dosing and monitoring visits. Pharmacist license and PharmD are essential.

Qualifications

• 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 1–2 years of hospital or compounding pharmacy experience required.
• Prior Clinical Research experience preferred.
• 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 per protocol.
• Sterile Compounding: maintain sterile environment and aseptic technique to ensure patient safety.
• Protocol & Blinding Adherence: follow blinded trial plans and protect unblinded IP information.
• IVRS/IWRS Management: navigate IRT systems for randomization and inventory management.
• Accountability & Documentation: maintain IP accountability logs for traceability of dispensed, returned, and destroyed product.
• Inventory Management: manage receipt/storage across ambient, 2–8°C, -20°C, -80°C, monitor temperature logs.

Skills

USP sterile compounding

Aseptic technique

IVRS/IWRS familiarity

BSA and weight-based dosing

Attention to detail

Communication skills

HIPAA compliance

Education

PharmD

Active Pharmacist license

IATA certification

Tools

IVRS/IWRS systems

Job description

Position Summary

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.
• May involve direct patient interaction during dosing or administration.
• 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

• $75-85/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.