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.

Essential Duties and Responsibilities:

1. 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.
2. Prepare reports and discuss non-compliance and/or quality findings with internal customers as well as with Quality management.
3. Track and follow up on the resolution of review findings.
4. Provide guidance to clinical staff in resolving findings, implementing processes, and CAPA plans (development, root cause analysis, implementation, and evaluation of CAPA plans).
5. Work closely with assigned clinical teams and site directors to identify gaps and ensure continuous process improvement in conjunction with Quality management.
6. Assist in preparing for inspections by sponsors and regulatory agencies and participate in on-site regulatory inspections as appropriate.
7. Assist in implementing quality management plans including risk identification and assessment through data review and quality control processes.
8. Provide consultation on corrective and preventive actions performed as a result of observations; follow-up and provide data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the site staff and operational team.
9. Assist with the development or enhancement of training materials.
10. Conduct on-the-job training (OJT) and instructor-led training (ILT) for employees and new hires.
11. Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum.
12. 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.
13. Identify and escalate significant compliance issues.
14. Share quality topics and lessons learned to the organization.
15. Assist individual sites in development of internal guidance documents to supplement corporate SOPs.
16. Assist with quality incident and compliance investigations.

Qualifications:

• Bachelor’s degree or equivalent experience
• Sound working knowledge of medical terminology, SOPs, ICH, GCP, FDA, applicable regulatory requirements, and quality management processes.
• 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role.
• Direct experience in the conduct and reporting of internal and external audits preferred.
• Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits preferred.
• Clinical Research or Quality Certification preferred
• 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 (Word, Outlook, Excel, PowerPoint, SharePoint, and Teams).
• Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment.

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