Research Quality Compliance (QC) Coordinator

Arizona Liver Health•Tucson, AZ

23h•Onsite

About The Position

Arizona Liver Health (ALH) / Arizona Clinical Trials (ACT) is seeking an experienced Quality Compliance Coordinator (QC) in Tucson 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.

Requirements

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.

Nice To Haves

Master’s Degree in healthcare, biosciences, or other related field preferred.

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).