Clinical Research Pharmacist

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 blindedunblinded 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 ManualSterile 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 eg 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 resolutionreporting 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 12 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

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

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Worksite address

sun city west, AZ, 85376, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.