Pharmacy Technician

p.MsoNormal, li.MsoNormal, div.MsoNormal {margin: 0.0in;font-size: 12.0pt;}*, serif {}*.MsoChpDefault {font-size: 10.0pt;}div.WordSection1 {page: WordSection1;}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {}* {} Overview of Position The Investigational Drug Services (IDS) Pharmacy Technician will play a critical role within the pharmacy team by supporting clinical trials and research studies. Under the supervision of the Director of Investigational Drug Services/ Pharmacist in Charge (PIC), the IDS Pharmacy Technician is responsible for ensuring the safe, accurate, and timely preparation, dispensing, and management of investigational drugs. This position requires strict adherence to regulatory guidelines and study protocols to maintain the integrity and success of clinical trials. Essential Functions Regulatory Compliance: · Follow all relevant regulations and guidelines including FDA, GCP, ICH, HIPAA, OSHA, and institutional policies. · Ensure proper documentation and record-keeping in accordance with regulatory requirements. Investigational Product (IP) Handling: · Assists pharmacist in pulling the correct study medication off the shelf as outlined in the study protocol. · Assists with maintaining accurate inventory logs in preparation for monitoring visits. Equipment Management: · Ensure that pharmacy equipment including glove boxes (CACI), analytical balances, incubators, thermometers, and data loggers are calibrated and maintained properly by keeping open communication with the appropriate vendors. · Ensure all equipment is in proper working condition and report any malfunctions immediately. Storage and Inventory Control: · Monitor and record drug storage conditions, such as temperature and humidity, to ensure compliance with study requirements. · Conduct regular inventory checks, manage drug expiration dates, and order new supplies as needed. · Ensure safe disposal of expired or unused investigational drugs according to regulations. Documentation and Record-Keeping: · Maintain thorough and accurate records for each clinical trial, including drug receipts, temperature logs, IP return/destruction records. · Organize and archive study documents, ensuring easy retrieval and compliance with audit requirements. Communication and Collaboration: · Act as a liaison between the IDS and clinical research teams. · Coordinate the delivery of IPs and materials to study sites and participants. · Contact drug manufacturers and vendors to order supplies and resolve any issues. Quality Assurance: · Participate in internal audits and quality assurance checks to ensure adherence to protocols and regulatory standards. · Identify and report any deviations or issues that may impact the integrity of the clinical trials. Continual Improvement and Training: · Stay updated on advancements in investigational drug handling and pharmacy practices. · Attend and contribute to regular staff meetings and training sessions. · Engage in professional development opportunities to enhance skills and knowledge. Qualifications Education: · High School Diploma required, preference for candidates with completed college coursework in a relevant field. Certifications and Licenses: · Current and clear Pharmacy Technician License in the State of California. · Valid California Driver's License. Salary: $28/hr.