Quality Assurance Coordinator - Hybrid

About the role

The Quality Assurance Coordinator conducts and assists with internal quality assurance monitoring and auditing activities for assigned clinical research studies at all participating sites under the CFCCC. Responsibilities include systematic clinical data monitoring and auditing, ensuring regulatory, subject management, data compliance, and Investigational Drug Service/Pharmacy research activities are in line with GCP and ICH guidelines.

Responsibilities

• Conducts and assists with internal quality assurance monitoring and auditing activities for assigned clinical research studies at all participating sites under the CFCCC.
• Reviews and verifies the timely and accurate submission of clinical trial data, reports findings.
• Interfaces with institutional faculty, administrators, industry sponsors, and regulatory agencies.
• Communicates with auditors, CFCCC research staff, and institutional research oversight offices/committees regarding audit dates and details.
• Coordinates external audits and facilitates communication between all parties.
• Serves as a point of contact for external audits and oversees the CAPA process to ensure completion, implementation, and effectiveness.

Requirements

• Strong understanding of clinical research conduct (GCP, ICH guidelines).
• Knowledge of current standard and novel investigational therapies in multiple therapeutic areas across Phase I, II & III trials.
• Experience reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings.
• Interpersonal skills and ability to interface with institutional faculty, administrators, and other staff, industry sponsors, and regulatory agencies.
• Flexibility, multitasking, and ability to work in a deadline-driven environment.
• Strong organizational and planning skills, attention to detail, and problem-solving abilities.
• Collegiality and cooperation with interdisciplinary teams.
• High-level communication skills, including handling difficult conversations and presentations.
• High level of integrity and honesty in maintaining confidentiality.
• Access to transportation to off-site research locations.
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.
• Preferred certifications: SoCRA or ACRP, or equivalent experience.
• Experience with monitoring or auditing FDA-regulated studies for highly complex clinical trials.
• Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored).
• Experience with cancer-related research.
• Experience with clinical trial professional certification from a professional society.

Qualifications

• Strong understanding of clinical research conduct (GCP, ICH guidelines).
• Knowledge of current standard and novel investigational therapies in multiple therapeutic areas across Phase I, II & III trials.
• Experience reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings.
• Interpersonal skills and ability to interface with institutional faculty, administrators, and other staff, industry sponsors, and regulatory agencies.
• Flexibility, multitasking, and ability to work in a deadline-driven environment.
• Strong organizational and planning skills, attention to detail, and problem-solving abilities.
• Collegiality and cooperation with interdisciplinary teams.
• High-level communication skills, including handling difficult conversations and presentations.
• High level of integrity and honesty in maintaining confidentiality.
• Access to transportation to off-site research locations.
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.
• Preferred certifications: SoCRA or ACRP, or equivalent experience.
• Experience with monitoring or auditing FDA-regulated studies for highly complex clinical trials.
• Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored).
• Experience with cancer-related research.
• Experience with clinical trial professional certification from a professional society.

Skills

• Strong understanding of clinical research conduct (GCP, ICH guidelines).
• Knowledge of current standard and novel investigational therapies in multiple therapeutic areas across Phase I, II & III trials.
• Experience reviewing/verifying the timely and accurate submission of clinical trial data, reporting findings.
• Interpersonal skills and ability to interface with institutional faculty, administrators, and other staff, industry sponsors, and regulatory agencies.
• Flexibility, multitasking, and ability to work in a deadline-driven environment.
• Strong organizational and planning skills, attention to detail, and problem-solving abilities.
• Collegiality and cooperation with interdisciplinary teams.
• High-level communication skills, including handling difficult conversations and presentations.
• High level of integrity and honesty in maintaining confidentiality.
• Access to transportation to off-site research locations.
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint).
• Related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience.
• Preferred certifications: SoCRA or ACRP, or equivalent experience.
• Experience with monitoring or auditing FDA-regulated studies for highly complex clinical trials.
• Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored).
• Experience with cancer-related research.
• Experience with clinical trial professional certification from a professional society.

Benefits

The University of California, Irvine (UCI) offers a comprehensive benefits package to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please visit the following link to learn more about our compensation practices and benefits: https://hr.uci.edu/new-hire/conditions-of-employment.php.

Pay

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Schedule

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