Research Quality Manager

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

📋 Description

• Execute the quality assurance program effectively.

• Oversee and conduct consultation/support visits at investigative sites.

• Aid in onsite external audits and inspections.

• Provide ongoing quality support for designated investigative sites.

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

• Assess and adjust policies and procedures as necessary.

• Apply quality tools to evaluate study-operation quality metrics.

• Monitor and prioritize quality metrics for all sites employing a risk-based strategy and Quality by Design framework.

• Identify and communicate quality deficiencies to directors and relevant colleagues.

• Assist in the creation and revision of process documents.

• Support in organizing and facilitating external audits.

• Help research personnel maintain regulatory compliance.

• Conduct process-focused audits of research sites and relay findings to leadership.

• Ensure prompt and appropriate follow-up on identified deficiencies.

• Share observations and deficiencies with 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 audit records and documentation.

• Communicate with clinical trial monitors and auditors as necessary.

• Educate staff on quality improvement techniques and industry developments.

• Perform additional duties as assigned.

⛳️ Requirements

• A Bachelor’s Degree is required.

• At least 3 years of work experience in Quality Assurance, Quality Management, or Quality Auditing, preferably within clinical research, healthcare, or life sciences.

• Proficient knowledge of Good Clinical Practice (GCP), FDA, and other relevant regulations within a risk-based setting.

• A Master’s Degree is preferred.

🏝️ Benefits

• Extensive benefits that promote physical, mental, and financial well-being.

• Eligibility for an annual bonus or long-term incentive opportunities may be available.

• Relocation assistance is not offered.

• Visa sponsorship is not available.