Quality Compliance (QC) Coordinator (Chandler)

 

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.

 

Role Summary 

Arizona Liver Health (ALH) is seeking an experienced Quality Compliance Coordinator (QC) in Chandler with a background in Clinical Research, Quality Compliance, and / or Regulatory Operations. As a key member of our team, you will play a crucial role in ensuring the highest standards of scientific excellence. 

Title: Quality Compliance Coordinator (QC) (Chandler, AZ)

Status: Full-time, Salaried

Work Schedule: Monday-Friday, 8am-5pm, Onsite

Essential job functions/duties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Ensure high integrity of data and patient safety at the research site through quality assurance review and management of the conduct of clinical research activities.
• Conduct routine data quality assurance checks,
• Review data for deviations, errors, omissions, or inconsistencies,
• Ensure studies are being conducted according to the applicable site SOPs,
• Work with the research staff and Principal Investigator to ensure identified issues are addressed in a timely and appropriate manner,
• Complete and review CAPAs as needed. Review CAPAs implementation as needed
• Work with clinic staff to address any audit findings from outside auditors (sponsor, CRO, IRB or FDA inspection findings)
• Ensure all required documentation is complete and appropriately filed.
• Liaison with study sponsors to resolve questions and/or concerns as needed
• Work with CRC to ensure understanding or required consistencies between source and EDC.
• Help in training research staff regarding QC (as designated)
• Meet with CRA at monitoring visits regarding findings. Engage other research staff as needed (regulatory coordinator, site manager, Director of Clinical Research).

Knowledge/Skills/Abilities Required

• A thorough understanding of regulatory requirements, principles of GCP and biomedical research ethics.
• Experience developing, managing, and reviewing Standard Operating Procedures (SOPs).
• Understanding of and experience in developing and supporting Corrective and Preventative Action Plans (CAPA).
• Ability to work independently, and in a fast-paced environment
• Attention to detail in all aspects of work
• Excellent collaboration skills
• Ability to work independently as well as in teams
• Excellent verbal and written communication skills
• Demonstrated ability to effectively organize and execute tasks
• Computer proficiency with Microsoft office and understanding of CTMS/EMR software
• High level of critical thinking

 

Education, credentials, and/or trainings required:

• Bachelor’s Degree in healthcare, regulatory affairs, biosciences, or other related field required.
• Master’s Degree in healthcare, biosciences, or other related field preferred.
• Good Clinical Practice (GCP) certification required.

Benefits & Perks:

• Health, Dental, Vision (with HSA plans and employer contribution)
• 3 weeks PTO
• 5 days Sick Time
• 7 Company holidays + 2 half-days
• 401K with company match (up to 6%)
• Short & Long Term Disability
• Educational Assistance
• Shared company vehicles for required travel

Travel requirements:

• Some interoffice travel may be required with use of company vehicle or mileage reimbursement

Work authorization 

• Must have valid documentation and authorization to work in the U.S. for any employer without sponsorship now or in the future. 

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