Arizona Liver Health · 1 day ago
Research Quality Compliance (QC) Coordinator
Chandler, AZ
Full-time
Onsite
Mid Level
$60K/yr - $75K/yrArizona Liver Health (ALH) is dedicated to advancing medical innovation through clinical trials and ensuring patient safety. They are seeking an experienced Quality Compliance Coordinator (QC) to ensure high standards of scientific excellence and manage quality assurance in clinical research activities.
Clinical TrialsHealth CareHospitalityMedical
No H1B
Responsibilities
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)
Qualification
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
Bachelor's Degree in healthcare, regulatory affairs, biosciences, or other related field required
Good Clinical Practice (GCP) certification required
Must have valid documentation and authorization to work in the U.S. for any employer without sponsorship now or in the future
Preferred
Master's Degree in healthcare, biosciences, or other related field preferred
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 company match (up to 6%)
Short & Long Term Disability
Educational Assistance
Shared company vehicles for required travel
Company
Arizona Liver Health
Arizona Liver Health provides specialized diagnostics, evaluation, treatment for patients with liver disease and other liver conditions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Anita Kohli
Physician, CEO
Michelle Jones
Sr. Vice President Commercial Operations | Clinical Trial Partnerships
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