Research Clinical Quality Manager - Remote US

Sarah Cannon Research Institute • Work at Home - Tennessee, USA (WTNA), TN

21h • Remote

About The Position

Our Research Quality Manager is responsible for implementing the quality assurance program, managing and performing consult/support visits at investigative sites, assisting with onsite external audits and inspections, and providing routine quality support for assigned investigative sites. This is a fully remote position in the US; relocation assistance and visa sponsorship are not available.

Requirements

• Bachelor’s Degree required
• Minimum 3 years’ work experience in Quality Assurance, Quality Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences field
• Expertise in GCP, FDA and other applicable regulations in a risk-based environment

Nice To Haves

• Master’s Degree preferred

Responsibilities

• Develops and maintains effective relationships with investigative sites and other SCRI departments and colleagues
• Monitors and modifies policies and procedures
• Utilizes quality tools that assess the quality indicators of study operations
• Monitors quality indicators for all sites using Risk-Based approach and within framework of QBD – Quality by Design - and prioritizes quality indicators depending on severity/urgency
• Identifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues
• Assists the business in development and modification of process documents
• Assists with preparation and hosting of external audits
• Assists research staff in maintaining regulatory compliance
• Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership.
• Ensures timely and appropriate follow-up in areas of deficiency.
• Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate.
• Assists sites with Root Cause analysis and responses to external audits and CAPAs.
• Maintains records of audits and reports.
• Communicates with monitors and auditors of clinical trials, as needed.
• Educates staff in quality improvement methods and industry trends
• Other duties as assigned

Benefits

• Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
• Competitive compensation package
• Annual bonus or long-term incentive opportunities may be offered

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level