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Clinical Trial Pharmacy Specialist

2 months ago

Torrance, California, United States International Executive Service Corps Full time
Position Overview


The Clinical Trial Pharmacy Specialist will be an integral member of the pharmacy team, dedicated to supporting clinical research initiatives and trials.

Under the guidance of the Director of Investigational Drug Services/Pharmacist in Charge (PIC), the Clinical Trial Pharmacy Specialist is tasked with ensuring the secure, precise, and prompt preparation, dispensing, and oversight of investigational medications.

This role necessitates strict compliance with regulatory standards and study protocols to uphold the integrity and success of clinical research.

Key Responsibilities

Regulatory Adherence:

  • Comply with all applicable regulations and guidelines, including FDA, GCP, ICH, HIPAA, OSHA, and institutional policies.
  • Maintain accurate documentation and record-keeping in line with regulatory obligations.

Investigational Product Management:

  • Assist the pharmacist in selecting the appropriate study medication as specified in the study protocol.
  • Help maintain precise inventory logs in preparation for monitoring visits.

Equipment Oversight:

  • Ensure pharmacy equipment, including glove boxes (CACI), analytical balances, incubators, thermometers, and data loggers, are properly calibrated and maintained through effective communication with relevant vendors.
  • Confirm all equipment is functioning correctly and report any malfunctions without delay.

Storage and Inventory Management:

  • Monitor and document drug storage conditions, such as temperature and humidity, to ensure compliance with study specifications.
  • Conduct regular inventory assessments, manage drug expiration dates, and reorder supplies as necessary.
  • Ensure the safe disposal of expired or unused investigational medications in accordance with regulations.

Documentation and Record Maintenance:

  • Keep thorough and accurate records for each clinical trial, including drug receipts, temperature logs, and investigational product return/destruction records.
  • Organize and archive study documents, ensuring easy access and compliance with audit requirements.

Collaboration and Communication:

  • Serve as a liaison between the Investigational Drug Services and clinical research teams.
  • Coordinate the delivery of investigational products and materials to study sites and participants.
  • Contact drug manufacturers and vendors to procure supplies and address any issues.

Quality Control:

  • Participate in internal audits and quality assurance evaluations to ensure adherence to protocols and regulatory standards.
  • Identify and report any deviations or issues that may affect the integrity of clinical trials.

Continuous Improvement and Training:

  • Stay informed about advancements in investigational drug management 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, with a preference for candidates who have 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.

Compensation:
$28/hr.