Job Description

Overview of responsibilities (day-to-day, metrics, etc): The Clinical Pharmacist ensures proper handling, dispensing, and regulatory compliance for investigational drug trials. Primary tasks include drug accountability, dosing, blinding, labeling, and both sterile and non-sterile compounding. They manage inventory (ordering, destruction, and returns), review study randomizations, and maintain accurate study records. Additionally, they serve as a resource for drug information, including side effects and cytochrome interactions, while maintaining clean room certifications and equipment calibration.

• Represent the organization professionally in all interactions, including verbal, written, and personal appearance, when engaging with sponsors, volunteers, vendors, and colleagues.
• Perform clinical trials pharmacy procedures after training, including drug accountability, dosing, blinding, labeling, compounding (sterile and non-sterile), dose preparation, quarantine, and emergency inventory management.
• Serve as a liaison with investigators, provide staff training, ensure compliance with study protocols, regulatory requirements, and safety standards such as OSHA.
• Maintain accurate and complete study records for all clinical studies.
• Review randomizations for each study prior to initiation.
• Manage inventory for investigational drug trials, including ordering, destruction, and processing returns as per study protocol.
• Support pharmacy participation in all clinical trials involving investigational drugs.
• Train and mentor pharmacy staff, update standard operating procedures (SOPs), and ensure timely and accurate completion of tasks.
• Meet with representatives from regulatory authorities (e.g., DEA, FDA).
• Assist department leadership in directing and supervising pharmacy technicians.
• Oversee importation of investigational drugs, ensuring adherence to all regulations.
• Maintain clean room certifications and ensure pharmacy equipment calibration.
• Write, update, and review SOPs related to pharmacy operations.
• Research, draft, and train staff on study-specific pharmacy procedures.
• Provide staff with drug information, including safety, side effects, and potential interactions.
• Read and follow study instructions, signing study responsibility logs as required.
• Be available on a rotational basis by pager or phone for off-site monitoring, temperature/humidity checks, and emergency unblinding procedures.
• Ensure all pharmacy procedures are performed accurately, on time, and in accordance with protocols and internal procedures.
• Keep all pharmacy areas clean, safe, and organized.
• Perform additional procedures or duties as required by specific study protocols.
• Request, schedule, and attend any required training to maintain competency.
• Supervise and ensure pharmacy technicians complete their assigned tasks accurately and on time.
• Notify supervisor of any issues, such as lack of training, ability, or other work-related problems.
• Follow written and verbal instructions, maintain punctuality, and demonstrate flexibility in scheduling.
• Perform other duties as assigned, noting that responsibilities may vary based on project or departmental needs.

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