Clinical Quality Specialist

JSC SCRI Holdings LLC • Full-time • Nashville, TN, USA - 1100 Dr. Martin Luther King Jr. Blvd. Suite 800 (J001) • 1w ago

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.

Job Description

Our Clinical Quality Specialist supports process improvement, and internal/external audits within the Investigative Site serving as the internal quality contact and resource for the department to support quality initiatives and projects.

Duties include and are not limited to:

Prepares for and hosts external sponsor / IRB audits
Assists sites with Root Cause Analysis and responses to external audits and CAPAs
Facilitate effectiveness checks to ensure CAPA closure
Reviews monitor letters for issue escalation and quality performance issues
Monitors quality indicators/quality check (QC) using risk-based approach within framework of Quality by Design (QbD).
Identifies areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate CQA staff.
Coordinates and facilitates quality review meetings with appropriate CQA staff and operational leadership
Communicates with monitors and auditors as needed
Assists research staff in maintaining regulatory compliance and QA standards
All other duties as assigned

Qualifications needed

Associate’s Degree required, Bachelor’s Degree preferred - Work experience may be substituted for education
Minimum 1+ year experience in a clinical research, pharmaceutical, biotech, or healthcare utilizing medical and clinical research terminology
Experience with Electronic Medical Record (EMR) highly preferred
Experience working in a fast-paced environment with a multi-team organization
Quality Assurance experience highly preferred

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 750 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 today. SCRI’s research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please 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.

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