Full-Time Quality Assurance Specialist (Clinical Research)

Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams.

Key Responsibilities:

• Travel to conduct internal quality assurance reviews of clinical trials and processes for adherence to SOPs, company policy, and regulations/standards.
• Prepare reports and discuss non-compliance and/or quality findings with internal customers and Quality management.
• Track and follow up on the resolution of review findings.
• Provide guidance to clinical staff in resolving findings, implementing processes, and CAPA plans (development, root cause analysis, implementation, and evaluation).
• Work with clinical teams and site directors to identify gaps and ensure continuous process improvement.
• Assist in preparing for inspections by sponsors and regulatory agencies, and participate in on-site inspections as appropriate.
• Assist in implementing quality management plans, including risk identification and assessment.
• Provide consultation on corrective and preventive actions.
• Assist with development or enhancement of training materials.
• Conduct on-the-job and instructor-led training for employees and new hires.
• Review training records to ensure compliance with training curriculum.
• Remain informed about developments in clinical trial requirements, FDA, ICH, GCP, and guidelines.
• Identify and escalate significant compliance issues.
• Share quality topics and lessons learned.
• Assist individual sites in developing internal guidance documents.
• Assist with quality incident and compliance investigations.

Qualifications:

• Bachelor's degree or equivalent experience
• Sound knowledge of medical terminology, SOPs, ICH, GCP, FDA, applicable regulations, and quality management processes.
• 3-5 years prior experience in clinical quality, clinical compliance, or clinical auditing.
• Direct experience in internal and external audits (preferred)
• Experience preparing for, participating in, and responding to health authority GCP inspections (preferred).
• Clinical Research or Quality Certification (preferred)
• Excellent communication (verbal and written) and interpersonal skills
• Client-focused approach
• Ability to work independently and manage multiple tasks
• Proficient in Microsoft Office programs (Word, Outlook, Excel, PowerPoint, SharePoint, Teams)
• Demonstrate tact, diplomacy, discretion, and good judgment

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