Lead Phase 1-3 Pharmacy Technician (AMP)

Arizona Liver HealthChandler, AZ
2d$28 - $35Onsite

About The Position

Arizona Liver Health (ALH) is dedicated to driving high standards of care and advancing medical innovation through leading clinical trials, ensuring patient safety and regulatory compliance, and generating high-quality clinical data. Our network of multiphase, multitherapeutic research, standard of care, and VEN Centers sites is staffed by skilled providers, research, clinic, pharmacy, and patient outreach professionals. ALH operates state-of-the-art facilities and programs to meet the evolving needs of clinical research and overall patient treatment. Arizona Liver Health/Arizona Clinical Trials is looking for qualified candidates for the Lead Phase 1-3 Pharmacy Technician (AMP) in Chandler, AZ.

Requirements

  • Ability to work independently with minimal day-to-day supervision.
  • Detail-oriented and committed to ensuring patient confidentiality.
  • Excellent motor skills and the ability to stand for long periods of time.
  • Advanced written and excellent verbal communication skills.
  • Data entry and computer skills.
  • Thorough understanding of clinical research requirements, principles of GCP, and biomedical research ethics. Must be GCP and IATA certified.
  • Experience in compounding non-sterile and sterile preparations.
  • Ability to interact effectively with professional and administrative staff, sponsor, regulatory representatives, patients, potential subjects, and referral sources.
  • Ability to provide all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum
  • High School Diploma required
  • Certification through the Pharmacy Technician Certification Board required
  • Bachelor’s degree, Associates degree, or Successful completion of a Pharmacy Technician program.
  • At least two (2) years experience as a pharmacy technician preferred but comparable experience will be considered.
  • Must have valid documentation and authorization to work in the U.S. for any employer

Nice To Haves

  • Previous clinical research experience as a pharmacy technician in phase 1-3 research highly preferred; candidates with this experience will be prioritized for consideration.

Responsibilities

  • Reviews protocols for Arizona Clinical Trials and Arizona Liver health
  • Ensure adherence to protocol during study conduct from a pharmacy perspective. Including but not limited to understanding drug requirements, preparation of drugs, and ensuring adequate administration of investigational product to study subjects, as well as ensuring that all required pharmacy-related equipment is available, properly maintained, and in good standing for use
  • Addressing protocol deviations and non-compliance issues.
  • Follow all health and safety protocols and procedures to maintain sanitary work areas.
  • Document investigational product handling, storage and dispensations in study specific pharmacy logs and Interactive Web Response Systems and oversee the documentation of pharmacy team members .
  • Verify patient information and label drug and research Investigational product correctly.
  • Ensure adherence to company procedures and standards for self and direct reports, not limited to proper documentation, following procedures for investigational product handling and storage.
  • Participate in sponsor audits and FDA inspections and ensuring continuous audit/inspection readiness by performing routine internal quality control inspections and review of pharmacy practices.
  • Review CRC schedule, verify, and complete orders in the electronic medical record and/or clinical trial manager system.
  • Facilitate transport of investigational products and related materials as required.
  • Maintain Pharmacy binders in pristine condition with completed paperwork required by the study.
  • Preparation of investigational product for dispensation.
  • Specialized functions/areas include but are not limited to the following: inventory control, medication maintenance, unit inspection and packaging.
  • Understand and comply with USP <795>, USP <797> and USP <800> requirements and DEA regulations.
  • Ensure compounding suite practices and operations are dutifully executed and documented.
  • Performing all duties related to unblinded pharmacy duties per protocol.
  • Utilizes requisite equipment, non-sterile and/or compounding supplies and computer systems as appropriate fort he procurement, preparation for verification, and/or delivery of medication.
  • Contributes to the maintenance of the pharmacy, equipment, and supplies.
  • Receives investigational drug supplies, handles return, and removes from stock investigational drugs from completed studies; dispenses investigational drug, maintain drug inventory, and review expiration dates.
  • Monitors temperatures daily if assigned via Hexmodal for all sites assigned, contacts study coordinators for clarifications and for proper temperature excursion procedures such as filing report and quarantining the affected investigational product.
  • Planning for pharmacy-related expenses such as and not limited to restocking supplies, stock, and emergency medications.
  • Ensure compliance with institutional, state, and federal regulatory policies.
  • Train and mentor on-boarding pharmacy staff at ACT Medical Park and other Arizona Liver Health sites. This includes assigning tasks, performing routine evaluations, and addressing emerging issues and concerns.
  • Aids with pharmacy-related training for any staff projected to participate in clinical trials.
  • Identify opportunities for process improvement and optimization by participating in the development of processes to ensure accuracy and integrity of research pharmacy operations.
  • Organize and manage documents and materials – sorting, labeling, filing, discarding per facility SOPs.
  • Answering research queries as designated by CRC’s. Assist with subject accountability and compliance
  • Training research staff and study participants on proper dosing requirements such as dosing procedures, medication compliance, dosing diary completion and review.
  • Participate in the training and orientation of new pharmacy technicians.
  • Perform all other duties as assigned. Work with investigators and clinical research coordinators and following their directions.
  • Proficiency across multiple studies in different phases for cross coverage at different research sites.

Benefits

  • Health, Dental, Vision (with HSA plans and employer contribution)
  • 3 weeks PTO
  • 5 days Sick Time
  • 7 Company holidays + 2 Half-days
  • 401K with 6% company match
  • Short & Long Term Disability
  • Educational Assistance
  • Shared company vehicles for required travel
  • Travel Requirements: Some inter-office travel may be required as needed with the use of a company vehicle or mileage reimbursement.
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