Research Quality Manager

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Execute the quality assurance program effectively.

• Oversee and conduct consultative/support visits at research sites.

• Aid in onsite external audits and inspections.

• Offer ongoing quality support for designated investigative sites.

• Build and sustain relationships with investigative sites as well as SCRI departments and colleagues.

• Review and adjust policies and procedures as necessary.

• Evaluate study-operation quality indicators utilizing quality tools.

• Monitor and prioritize quality indicators across all sites through a risk-based approach and Quality by Design framework.

• Detect quality deficiencies and communicate them to SC Directors and relevant colleagues.

• Assist in the creation and revision of process documentation.

• Help prepare for and facilitate external audits.

• Support research personnel in upholding regulatory compliance.

• Conduct process-focused audits of research sites when required and report findings to leadership.

• Ensure prompt and appropriate follow-up on deficiencies.

• Relay observations and deficiencies to Site Directors/Managers and study Principal Investigators (PIs).

• Assist sites with root-cause analysis and responses to external audits and Corrective and Preventive Actions (CAPAs).

• Maintain records and reports of audits.

• Communicate with clinical trial monitors and auditors as necessary.

• Educate staff on quality improvement strategies and industry advancements.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s Degree is required.

• A Master’s Degree is preferred.

• At least 3 years of experience in Quality Assurance, Quality Management, or Quality Auditing is required.

• Experience in clinical research, healthcare, or life sciences is preferred.

• Proficiency in Good Clinical Practice (GCP), FDA, and other relevant regulations in a risk-based setting is essential.

• This position is remote within the US.

• Relocation assistance will not be provided.

• Visa sponsorship is not available.

🏝️ Benefits

• Comprehensive benefits that promote physical, mental, and financial wellness.

• Competitive compensation package.

• Opportunities for annual bonuses or long-term incentives may be available.

• Relocation assistance will not be provided.

• Visa sponsorship is not available.