Research Quality Manager

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

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

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

Duties include but are not limited to:

• 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

Qualifications needed

• Bachelor’s Degree required, Master’s Degree preferred
• 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

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.

click here to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.