Quality Assurance Coordinator - Hybrid

University of California, Irvine•Orange, CA

1d•Hybrid

About The Position

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 for the overall review of regulatory, subject management, data compliance, and Investigational Drug Service/Pharmacy research activities under the direction of the Quality Assurance Officer. Quality Assurance activities comprise of systematic clinical data monitoring and auditing which includes informed consent process and documentation verification, subject eligibility confirmation, electronic medical record review, review for documentation and reporting of serious adverse events/adverse events, Investigational Drug Service/pharmacy record review, deviation review and reporting, confirmation of regulatory compliance, overall protocol compliance, and compliance with all applicable university policies and federal regulations. Additionally, the Quality Assurance Coordinator leads and coordinates external audits under the direction of the Quality Assurance Officer. The Quality Assurance Coordinator will communicate with the auditor, all applicable CFCCC research staff and institutional research oversight offices/committees (e.g. UCI IRB and UCI Health Compliance & Privacy Office) regarding audit dates and pertinent details. The Quality Assurance Coordinator will also work with study teams to ensure all relevant and requested documents are adequately prepared and present. The Quality Assurance Coordinator serves as a point of contact for external audits and will facilitate communication between all parties. The Quality Assurance Coordinator will also oversee the corrective and preventive action (CAPA) process to ensure completion, implementation, and effectiveness as required.

Requirements

Strong understanding of clinical research conduct (GCP, ICH guidelines) with knowledge of both 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
Strong interpersonal skills and ability to interface with institutional faculty, administrators and other staff, industry sponsors and regulatory agencies
Ability to be flexible, multitask and switch priorities as well as work comfortably in a deadline driven environment
High-level communication skills including difficult conversation and presentation skills
Strong organizational and planning skills, attention to detail, and ability to solve complex problems as well as handle multiple projects/problems simultaneously
Ability to work collegially and cooperatively and to establish and maintain cooperative working relationships as a member of an interdisciplinary team
Skill in interacting with persons of various social, cultural, economic and educational backgrounds
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) and ability and openness to learn and become proficient with new software and web interfaces quickly.
3-5 years of related work experience with a Bachelor of Arts/Bachelor of Science, or equivalent experience

Nice To Haves

Society of Clinical Research Administrators (SoCRA) or Association of Clinical Research Professions (ACRP) certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research) or equivalent
Experience with monitoring or auditing FDA regulated studies for highly complex clinical trials
Experience with cancer-related research
Knowledge with various types of human subject clinical trials (i.e., National Group, Industrial, and Investigator-authored)
Clinical Trial Professional certification from a professional society

Responsibilities

Conducts and assists with internal quality assurance monitoring and auditing activities for assigned clinical research studies.
Oversees the overall review of regulatory, subject management, data compliance, and Investigational Drug Service/Pharmacy research activities.
Performs systematic clinical data monitoring and auditing, including verification of informed consent process and documentation.
Confirms subject eligibility and reviews electronic medical records.
Reviews documentation and reporting of serious adverse events/adverse events.
Reviews Investigational Drug Service/pharmacy records.
Reviews and reports deviations.
Confirms regulatory compliance and overall protocol compliance.
Ensures compliance with all applicable university policies and federal regulations.
Leads and coordinates external audits under the direction of the Quality Assurance Officer.
Communicates with auditors, CFCCC research staff, and institutional research oversight offices/committees regarding audit dates and details.
Works with study teams to ensure adequate preparation and presentation of relevant documents.
Serves as a point of contact for external audits and facilitates communication between all parties.
Oversees the corrective and preventive action (CAPA) process to ensure completion, implementation, and effectiveness.