Clinical Quality Specialist Work From Home
This is a Work From Home position, but you must be located in the Kansas City, MO area for this role as it supports our Sarah Cannon Kansas City site location.
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:
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 and Responsibilities
Duties include but are not limited to:
Prepares for and hosts external sponsor / IRB audits
Investigates and responds to Corrective and Preventive Action (CAPA) requests in collaboration with Clinical Operations and CQA.
Works with Clinical Operations to obtain evidence of deliverables and facilitates effectiveness checks as needed to ensure CAPA closure.
Reviews monitor letters for issue escalation and quality performance issues
Develops a calendar for monitoring quality indicators/quality check (QC) and provides routine reporting of variances to the appropriate Clinical Quality Assurance (CQA) staff and operational leadership
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
Monitors, coordinates, and assists with procedure modification for quality management as required.
Assists in development and modification of departmental work instructions and collaborates with appropriate CQA staff to ensure alignment with SOPs
Educates research staff in quality improvement methods
Assists research staff in maintaining FDA compliance
Performs related work as required
Minimum Required: Associate Degree (2 year program)
Preferred: Bachelor's College Degree (4 year program)
Experience in clinical research ideally working in a clinical quality department or site
Excellent written and verbal communication skills
Organization skills and ability to multi-task various responsibilities
Professional Research Certification: ACRP or SoCRA certification
Quality assurance, quality management or quality auditing experience in a clinical research organization or sponsoring company
Experience in a clinical trial environment preferably a Site Management Organization (SMO), Contract Research Organization (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.