Remote Research Quality Manager for Oncology Trials

Sarah Cannon Research Institute; Nashville (TN); Remote; USD 100,000 - 140,000; Full time

Benefits offered by this job

Total Rewards package

Bonus potential

Job summary

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials to advance cancer therapies and improve patient outcomes across the United States. The Research Quality Manager will implement the QA program, manage consult visits at investigative sites, assist with audits, and ensure regulatory compliance.

This is a remote position in the US; relocation assistance and visa sponsorship are not available.

Qualifications

• Bachelor’s Degree required; Master’s Degree preferred.
• Minimum 3 years’ experience in Quality Assurance/Quality Management or Quality Auditing in clinical research or life sciences.
• Expertise in GCP, FDA and applicable regulations in a risk-based environment.

Responsibilities

• Develops and maintains effective relationships with investigative sites and SCRI colleagues.
• Monitors and modifies policies and procedures.
• Utilizes quality tools to assess study operation quality indicators.
• Monitors quality indicators for all sites using a risk-based approach and QBD framework.
• Identifies deficiencies and reports to SCRI Directors and appropriate colleagues.
• Assists with development and modification of process documents.
• Assists with preparation and hosting of external audits.
• Maintains regulatory compliance with research staff and conducts audits as needed.
• Communicates observations to Site Director/Manager and study PI.
• Supports Root Cause analyses and CAPAs.

Skills

Quality Assurance

Clinical Research

GCP

FDA Regulations

Education

Bachelor's Degree

Master's Degree

Job description

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization conducting community-based clinical trials to advance cancer therapies and improve patient outcomes across the United States. The Research Quality Manager will implement the QA program, manage consult visits at investigative sites, assist with audits, and ensure regulatory compliance.

This is a remote position in the US; relocation assistance and visa sponsorship are not available.