Clinical Research Pharmacist

Elite Clinical Network; San Jose (CA); On-site; USD 103,000 - 117,000; Full time

Job summary

Elite Clinical Network seeks a Clinical Research Pharmacist (PRN) to manage investigational product operations for complex studies, ensuring compliant prep, aseptic technique, and strict adherence to GCP and USP standards. You will collaborate with Site Directors, investigators, and staff to support safe, ethical research.

The role requires 1–2 years in hospital or compounding pharmacy, PharmD and active license, and IATA certification or willingness to obtain.

Qualifications

• PharmD degree required and active Pharmacist license.
• IATA certification or willingness to obtain within 30 days of hire.
• 1–2 years hospital or compounding pharmacy experience required.

Responsibilities

• Prepare, compound, and dispense IV infusions, injections, and oral meds per protocol.
• Maintain sterile environment and aseptic technique per USP standards.
• Follow Blinding Plan to prevent unblinding of staff or participants.
• Manage IP inventory using IVRS/IWRS systems.
• Maintain IP Accountability Logs for traceability of dispensed, returned, and destroyed product.
• Oversee IP receipt and storage across ambient, 2‑8°C, -20°C, -80°C with temperature logs.
• Assist CRAs during monitoring visits and resolve queries.
• Maintain pharmacy regulatory binders and study documentation for FDA/GCP compliance.

Skills

USP Sterile Compounding

IVRS/IWRS Familiarity

Body Surface Area

Dosing Calculations

Attention to Detail

Communication Skills

HIPAA Compliance

Education

PharmD

Active Pharmacist License

IATA Certification

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.