Clinical Research Pharmacist

ECN Clinical; San Diego (CA); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

ECN Clinical is seeking a Clinical Research Pharmacist to manage investigational product operations for studies requiring aseptic technique. You will ensure compliance with FDA, GCP, and USP standards while collaborating with the Site Director, investigators, and study staff.

The role involves IV infusions, sterile compounding, IP accountability, and use of IRT systems, with travel to sites for dosing and monitoring visits.

Formación

• PharmD degree required; active pharmacist license in the state of practice.
• IATA certification for shipping dangerous goods (or willingness to obtain within 30 days).
• Experience with USP sterile compounding standards and hazardous drug handling.

Responsabilidades

• Prepare, compound, and dispense IV infusions, subcutaneous injections, and oral meds per protocol.
• Maintain sterile environment and aseptic technique for sterile compounds.
• Adhere to Blinding Plan to prevent unblinding during randomized trials.
• Navigate IRT systems for subject randomization, kit assignment, and inventory.
• Maintain IP accountability logs for traceability and regulatory compliance.
• Oversee IP receipt/storage across ambient and cold conditions; monitor temp logs.
• Meet CRAs during monitoring visits to review pharmacy binders and drug records.
• Support audit readiness by organizing regulatory binders and study docs.

Conocimientos

USP Proficiency

IVRS/IWRS

BSA and weight-based dosing

Complex dilution factors

Attention to detail

Communication skills

HIPAA familiarity

Educación

Doctor of Pharmacy (PharmD)

Active pharmacist license

IATA certification for shipping dangerous goods

Descripción del empleo

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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, 2-8°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.

Equal Opportunity Employer:

ECN Clinical 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.