Geared toward candidates with a background in clinical research and regulatory operations who are comfortable with ensuring data integrity and addressing audit findings.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Arizona Liver Health
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) / 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.
Title: Quality Compliance Coordinator (QC)
Location: Tucson, AZ
Status: Full-time, Salaried, $60,000 - $75,000 per year depending on experience
Work Schedule: Monday-Friday, 8am-5pm
1 opening
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)
2 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.
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 and pushy inquires may also be blocked across our network as spam. Thank you for your understanding and cooperation
Source: Arizona Liver Health careers