Quality Monitoring & Compliance Lead - Irvine, CA

Overview

As a Clinical Quality Compliance Specialist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Support Clinical study team on the development of Quality Control Plans and perform implementation of quality control activities for assigned projects according to agree upon timelines
• Conduct Quality Control activities which include, but are not limited to the following:
  • Support Quality reviews of clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations.
  • As applicable, review quality of Study Reports and Publications to confirm that the study was performed in accordance with the agreed upon protocol, regulatory requirements and that the clinical study is accurately and completely reported
    Review of Trial Master File to ensure accuracy and completeness of the documentation.
  • Perform and/or support the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.
  • Support Clinical R&D preparation, conduct and response to internal and external audits.
  • Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review, and communicate trends with Clinical Trial Core teams.
  • Using available systems tools (e.g., EDC, CTMS and eTMF generated dashboards and reports), support compilation of monthly project performance metrics for department by organizing, analyzing, preparing presentation, and facilitating Clinical Management Review (CMR) meeting.
  • Identify problems through analysis of project performance metrics and, with support of Quality Systems Leader, recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits.
  • Support Clinical R&D CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical R&D CAPAs.
  • Actively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical R&D, as applicable, to resolve any identified issues/problems.
  • May visit sites with Monitors to improve site performance as necessary.
  • Participate in/support FDA BIMO audit preparation and execution.
• Responsible for tracking training/updating curriculums for all Clinical R&D associates, working with the relevant associates across the campus sites to ensure compliance with all training requirements.
• May be involved in other tasks to support Clinical R&D, as needed.
• Participate in Clinical Trial/Study Core Team meetings, as required.
• Provide internal communication of important clinical data and event.
• Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
• Participate in departmental initiatives across the Clinical R&D aimed at improving process and efficiency, for the improvement of local processes
• Support Quality Systems Leader in ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
• Participate in project management meetings and provide an overview of clinical quality and workload as needed.

Qualifications

You are:

• Located in the Irvine, CA area. (hybrid role)
• Minimum Bachelors/University degree
• 4-6 years of Clinical Quality experience and requires at least 2-3 years of Clinical Quality Control/Assurance experience
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
• Requires understanding and application of GCP regulations and standards applied in clinical areas and MedTech/combination products
• Medical Device or Clinical Research background required (Cardio experience is a plus but not required).
• Clinical Monitoring background a plus.
• Understanding of applicable FDA regulations, EU Directive, and ISO 14155
• Understanding of quality control application in clinical research
• Certifications such as CCRA or RAC are a plus.
• Hands-on involvement in audit preparation and regulatory compliance.
• Strong skills and demonstrated competencies in the following areas are required:
• Understanding of quality control application in clinical research
• Knowledge and understanding of the processes involved in conducting a clinical trial
• Excellent interpersonal, communication and presentation skills
• Change Management
  • Presentation and Influencing

Pay Range ($100,472.00/Yr. USD - $125,590.00/Yr USD)

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.