Lead Phase 1 Research Pharmacy Technician (AMP)

Job Description

Job Description

About Us :

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.

Job Summary :

Arizona Liver Health / Arizona Clinical Trials is looking for qualified candidates for the Lead Phase 1 Research Pharmacy Technician (AMP) in Chandler, AZ.

Title : Lead Phase 1 Research Pharmacy Technician (AMP)

Compensation : $27 - $35 per hour, depending on experience

Work Schedule : Monday-Friday, 7 : 00a - 4 : 00p (set schedule)

Location : Chandler, AZ (Onsite)

Key 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 oversee the documentation of direct reports.
• 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 binder 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 : hazardous drugs handling, sterile compounding, inventory control, medication maintenance, unit inspection and packaging.
• Performing all duties related to unblinded pharmacy duties per protocol.
• Utilizes requisite equipment, non-sterile and / or compounding supplies and computer systems as appropriate for the 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.
• Proficient in oncology, USP 800 & 797 guidelines and processing, and DEA regulatio.

Knowledge, Skills, and Abilities :

Education and Experience :

Benefits :

Travel Requirements :

Work authorization requirements

Our company requires COVID-19 vaccinations for all current and future employees (& temporary employees). Exemptions can be requested for those with a reasonable health or a religious / sincerely -held belief accommodation.

EEO Statement :

It is the policy of the Institute for Liver Health DBA Arizona Liver Health and Arizona Clinical Trials to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities. Provisions in applicable laws providing for bona fide occupational qualifications, business necessity or age limitations will be adhered to by the company where appropriate.

Notice to Staffing Agencies : It is our policy that any and all contact with third party staffing or recruitment vendors come through our Talent Acquisition Team directly. We have an established and preferred network of contracted partners that we engage if and when we deem it necessary. We request that staffing agencies refrain from repeatedly contacting our hiring managers or employees directly. Unsolicited resumes, onsite solicitations, and inquiries will not be considered or responded to. Overly persistent or forceful inquires may also be blocked across our network at the domain level as spam. Thank you for your understanding.