Clinical Research Pharmacist

Elite Clinical Network; San Diego (CA); Vor Ort; USD 120.000 - 180.000; Teilzeit

Zusammenfassung

Elite Clinical Network is seeking a Clinical Research Pharmacist in San Diego to coordinate investigational product operations for complex studies, ensuring compliance with GCP, USP, and regulatory standards. The role collaborates with site staff to support safe, ethical research and site readiness.

The position requires PharmD, active license, and IATA shipping certification. 1–2 years hospital or compounding pharmacy experience, with expertise in sterile compounding and IP handling, is

Qualifikationen

• PharmD degree required with an active, unrestricted license in the practice state.
• IATA certification for shipping dangerous goods (or willingness to obtain within 30 days).
• Minimum 1–2 years hospital or compounding pharmacy experience.

Aufgaben

• Prepare, compound, and dispense IV infusions, injections, and oral meds per protocol.
• Maintain sterile environment and aseptic technique for USP-compounded products.
• Follow Blinding Plan to prevent unblinding of IP information.
• Manage IP tracking via IRT/IRT systems for randomization and inventory.
• Maintain IP accountability logs for traceability of dispensed, returned, and destroyed product.
• Oversee IP receipt and storage under ambient and controlled temperatures; monitor logs and excursions.
• Review pharmacy binders and drug accountability during CRA visits; resolve queries.
• Support audit readiness with FDA, GCP, and Sponsor document compliance.

Kenntnisse

USP sterile compounding

IVRS/IWRS familiarity

BSA dosing

Weight-based dosing

Dosing calculations

Attention to detail

Communication skills

HIPAA knowledge

Ausbildung

PharmD

Active pharmacist license

IATA Certification

Tools

IVRS/IWRS systems

Jobbeschreibung

Position Summary:

The Clinical Research Pharmacist 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, 2-8C, -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.

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.

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.