**Our company requires COVID-19 vaccination in order to comply with all federal and state mandates. Weekly testing will be required for candidates/employees with a religious or health accommodation.

AZ Liver Health is looking for qualified candidates for their Quality Assurance/Control Coordinator position.

*Foreign MD grads are encouraged to apply and gain further medical/research experience!

Job Summary

This position uses critical thinking and research expertise to monitor and audit research conducted at Arizona Liver Health to confirm compliance with applicable federal, state and local regulatory, sponsor requirements, and regulatory review committee (IRB, IACUC, IBC, etc.) policies and procedures.

Essential Functions

• Review and audit proposed and active clinical research studies; interpret research regulations and identify investigator compliance with regulations and requirements relative to clinical settings.
• Prepares, analyzes, and interprets a variety of documentation and ensures correct application of intended guidance.
• Track assigned research projects utilizing a risk-based assessment tool to prioritize research studies for in-depth review.
• Support up-to-date institutional policies for research review and approval, research execution, and publication clearance to comply with local and federal agencies.
• Analyze data from audits and protocols, prepare reports, and communicate results with suggested corrective actions to the research team.
• Audits research records, source documentation, and/or billing practices to monitor compliance with applicable regulations. Identifies areas of potential risk through audit processes, as well as assists with presentation of audit findings and design and monitoring of necessary corrective action.
• Assists in providing monitoring support for all facets of clinical trials and research. Performs monitoring visits to assure the research data with accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents. Researches regulatory and billing requirements and develops audit tools and report forms at the direction of the compliance leadership team.
• Identifies training opportunities based on audits, designs and presents such education to prevent repeated compliance risks.
• Provides compliance/documentation education sessions to providers, investigators, and research team.
• Maintains awareness of applicable laws, regulations and practices to maintain research compliance. Reviews related policies and procedures and literature. Communicates applicable coding/compliance issues to the providers and research team.
• Assumes additional responsibilities to assist and support the research team and unique situations and problems.

Minimum Qualifications

• BS/BA degree and 3+ years of relevant work experience with increasing responsibility in data and/or quality management and knowledge of many therapeutic area, OR and equivalent combination of education and experience, is required.
• Proficiency in using MS Office programs and web applications
• Demonstrated time management skills and ability to adhere to project productivity metrics and time lines.
• Knowledge of clinical trial process and data management, clinical operations, quality management, and systems applications to support operations
• Proven knowledge of SOPs, GCPs and local/international regulations
• Ability to analyze data, share information and make recommendations for improvements
• A strong team player, with excellent organizational and problem solving skills and the ability to work independently. Must be able to multi-task and work well within a high pace pressurized environment
• Proficient in decision making, problem-solving, prioritizing, critical thinking and analytical skills

Preferred Qualifications

Advanced degree, Professional designations such as Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA), or Certified in Healthcare Research Compliance (CHRC) are strongly desired.

Expertise in human subject protections and the following standards/regulations:

• Federal Code of Regulations
• ICH/GCP (International Conference of Harmonization / Good Clinical Practice)
• FDA regulations
• OHRP (Office of Human Research Protection)

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Application Question(s):

• What is a good email for HR to reach you at?

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Research: 1 year (Required)

Work Location: One location

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