HCA, Hospital Corporation of America Clinical Quality Assurance Specialist in Nashville, Tennessee
Clinical Quality Assurance Specialist
Sarah Cannon, the Cancer Institute of HCA Healthcare, offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation provided by oncology-trained nurses, more than 1,000 stem cell transplants performed annually throughout the Sarah Cannon Blood Cancer Network, hundreds of clinical trials, and molecular profiling capabilities. Through its services, Sarah Cannon is providing state-of-the-art cancer care close to home for hundreds of thousands of patients, a number unmatched by any single cancer center.
By bringing together a network of globally-recognized cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 260 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.
Summary of Position: Provides guidance and support to Sarah Cannon Development Innovations processes to meet GCP and regulatory requirements in the conduct of clinical trials. Assists in hosting Sponsor and regulatory inspections and conducts internal and site audits as assigned. Works closely and effectively with Development Innovations, Quality Management, research Directors, clinical trial Sponsors, clinical study teams, site colleagues, and outside consultants.
Duties and Responsibilities
Duties include but are not limited to: * Providing guidance to research operations on the interpretation of regulatory requirements (standard/ policies/ procedures) related to quality assurance and GCP * Performing quality functions and executing quality programs to support CRO processes * Assisting in the preparation, hosting, and follow-up of Sponsor audits/ assessments and regulatory inspections * Participating in the development and/ or review of standards, policies, procedures, and work instructions to support the quality management system and CRO processes * Conducting internal and site audits, including planning, executing, reporting, follow-up * Providing guidance and support for non-conformances and corrective and preventive actions required by CRO activities * Developing quality plans as appropriate * Identifying areas of deficiency and trends in quality and escalating to appropriate colleagues * Developing, modifying, and utilizing tools to track compliance issues * Developing timelines to ensure timely and appropriate follow-up in areas of deficiency * Maintaining records to support quality processes and audits * Educating, training, and mentoring staff in quality improvement methods * Attending training courses, conferences or association meetings to continue to gain knowledge and share information with other members of the group or company to increase awareness of industry trends * Participating in divisional improvement efforts * Performing related work as required * Travel up to 10%, as assigned
_Education:_ Minimum Required:Associate Degree (2 year program) Preferred:Bachelor’s College Degree (4 year program)
_Experience:_ Minimum Required: * Experience in clinical research Preferred: * Quality assurance, quality management or quality auditing experience in a clinical research organization or sponsoring company * Experience in a clinical trial environment preferably a CRO or sponsor company * Demonstrated leadership skills
Do you find this opportunity compelling, if so we encourage you to apply? We promptly review all applications. If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.
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.
Job: *Case Management
Title: Clinical Quality Assurance Specialist
Location: Tennessee-Nashville-Sarah Cannon Clinical Operations
Requisition ID: 25320-5563