Job Details
Job Location
Torrance Campus - Torrance, CA
Position Type
Full Time
Salary Range
$28.00 - $28.00 Hourly
Description
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.
Experience: - Previous experience as a pharmacy technician, ideally within a hospital or clinical research setting. - Familiarity with investigational drug services, clinical trials, and regulatory compliance.
Skills and Competencies: - Exceptional attention to detail and superior organizational skills. - Demonstrated ability to execute repetitive tasks with high accuracy - Advanced proficiency in mathematical calculations for precise drug dosages. - Expertise in operating pharmacy software system, MS Office Suite (Word, Excel, Outlook). - Outstanding communication skills, both verbal and written. - Proven ability to work independently and collaboratively within a team. - Adaptable to changing environments and able to assist clients in a courteous and professional manner. - Strong problem-solving capabilities and adept at managing multiple tasks under tight deadlines.
Physical Requirements & Working Conditions: - Proficient in verbal and auditory communication, ensuring clear and effective exchanges. - Primarily desk-based tasks with periodic standing and walking duties. - Highly capable in manual dexterity for handling and reaching activities. - Light lifting required (up to 10 pounds) with support available for heavier lifts up to 50 pounds. - Excellent close vision and ability to focus on detailed computer work. - Potential exposure to mechanical components, airborne particles, fumes, chemicals, and a slight risk of electrical hazards. - Work environment usually maintains a low noise level.
Confidential Information Management : - The Investigational Drug Service (IDS) files contain highly privileged scientific and personal information. - It is imperative that this sensitive information is managed with the utmost level of confidentiality and care, adhering strictly to regulatory and ethical guidelines to protect the privacy and integrity of all involved parties.