Early Phase Clinical Pharmacist - 251749
hace 4 días
San Antonio
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.