Quality Assurance Specialist

Summary

Join M3 Wake Research as a Quality Assurance Specialist and contribute to the quality and compliance of clinical trials. This remote position, with up to 40% travel, involves conducting quality assurance reviews, collaborating with clinical research staff, and ensuring compliance with regulations. You will prepare reports, provide guidance, assist with inspections, and implement quality management plans. The role requires strong communication, organizational, and problem-solving skills, along with experience in clinical quality or auditing. M3 Wake Research offers competitive wages and a comprehensive benefits package.

Requirements

• Bachelor’s degree or equivalent experience
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), applicable regulatory requirements, and quality management processes
• 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role
• Excellent interpersonal, verbal, and written communication skills
• Client focused approach
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams
• Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment

Responsibilities

• Travel to M3 Wake Research sites 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 as well as with 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 to include development, root case analysis, implementation, and evaluation of CAPA plans
• Work closely with assigned clinical teams and site directors to identify gaps and ensure continuous process improvement in conjunction with Quality management
• Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate
• Assist in implementing quality management plans including risk identification and assessment through data review and quality control processes
• Provides consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the site staff and operational team. Assist with the development or enhancement of training materials
• Conducts on-the-job training (OJT) and instructor-led training (ILT) for employees and new hires
• Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum
• Remain informed about developments in relevant clinical trial requirements, FDA, ICH, GCP, and guidelines within the US and other regions, as appropriate for M3 Wake Research
• Identify and escalate significant compliance issues
• Share quality topics and lessons learned to the organization
• Assist individual sites in development of internal guidance documents to supplement corporate SOPs
• Assist with quality incident and compliance investigations

Preferred Qualifications

• Direct experience in the conduct and reporting of internal and external audits
• Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits
• Clinical Research or Quality Certification

Benefits

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance