Quality Assurance Specialist (Clinical Research) - Remote

Overview

The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams, collaborating with clinical research staff to ensure compliance and continuous quality enhancement.

In Short

• Conduct internal quality assurance reviews of clinical trials.
• Prepare reports on non-compliance and quality findings.
• Provide guidance to clinical staff for resolving findings.
• Assist in preparing for inspections by sponsors and regulatory agencies.
• Implement quality management plans including risk assessments.
• Conduct on-the-job and instructor-led training for employees.
• Ensure compliance with training curriculum at assigned sites.
• Stay informed about clinical trial requirements and guidelines.
• Assist with quality incident and compliance investigations.
• Share quality topics and lessons learned within the organization.

Requirements

• Bachelor’s degree or equivalent experience.
• Knowledge of medical terminology, SOPs, ICH, GCP, FDA regulations.
• 3-5 years of experience in clinical quality or compliance roles.
• Experience with internal and external audits preferred.
• Clinical Research or Quality Certification preferred.
• Excellent communication skills.
• Ability to work independently and manage multiple tasks.
• Proficient in Microsoft Office programs.
• Ability to demonstrate tact and good judgment.

Benefits

• 401(k) with matching.
• Dental and health insurance.
• Disability and life insurance.
• Paid time off.
• Flexible spending account.
• Employee assistance program.
• Vision insurance.