Quality Assurance Specialist Clinical Research

Wake Research; Raleigh (NC); Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Specialist to enhance clinical trial quality through comprehensive reviews and audits. This role involves collaborating with clinical teams to ensure compliance with SOPs and regulatory standards, providing recommendations for improvement, and conducting training for staff. The ideal candidate will have a strong background in clinical quality assurance, excellent communication skills, and the ability to manage multiple tasks effectively. Join a dynamic organization where your contributions will drive continuous quality enhancement and compliance in clinical research.

Benefits

401(k) matching

Dental insurance

Disability insurance

Employee assistance program

Flexible spending account

Health insurance

Life insurance

Paid time off

Vision insurance

Qualifications

• 3-5 years experience in clinical quality, compliance, or auditing roles.
• Knowledge of FDA, ICH, GCP, and quality management processes.

Responsibilities

• Conduct internal quality assurance reviews and audits at clinical sites.
• Provide guidance to clinical staff on compliance and corrective actions.

Skills

Interpersonal Skills

Communication Skills

Attention to Detail

Organizational Skills

Client-focused Approach

Ability to Work Independently

Flexibility

Teamwork

Education

Bachelor's Degree

Tools

Microsoft Office

SharePoint

Teams

Job description

Job Description

The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams. This role involves collaborating with clinical research staff to address findings, provide recommendations for improvement, and ensure compliance within their area of expertise. The Quality Assurance Specialist will oversee audits and inspections, and work cross-functionally to support continuous quality enhancement across the organization.

Essential Duties and Responsibilities:

Including, but not limited to the following:

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

Qualifications:
Qualifications

1. Bachelor’s degree or equivalent experience.
2. 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. 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role.
4. Direct experience in the conduct and reporting of internal and external audits preferred.
5. Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits also preferred.
6. Clinical Research or Quality Certification preferred.
7. Excellent interpersonal, verbal, and written communication skills.
8. Client-focused approach.
9. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning.
10. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills.
11. Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization.
12. Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams.
13. Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment.

Benefits:

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

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

*M3 reserves the right to change this job description to meet the business needs of the organization

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