Clinical Quality Specialist

Research Medical Center

Posted Under: Kansas City, Kansas jobs in Healthcare; Healthcare jobs in zipcode 66101
Posted On: 2019-10-11 00:00:00

Description SHIFT: Work From Home

SCHEDULE: Full-time

ClinicalQuality 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.----SarahCannon, the Cancer Institute of HCA Healthcare, offers integratedcancer services with convenient access to cutting-edge therapies for thosefacing cancer in communities across the United States and United Kingdom. SarahCannon---s cancer programs include individualized patient navigation provided byoncology-trained nurses, more than 1,000 stem cell transplants performed annuallythroughout the Sarah Cannon Blood Cancer Network, hundreds of clinical trials,and molecular profiling capabilities. Through its services, Sarah Cannon isproviding state-of-the-art cancer care close to home for hundreds of thousandsof patients, a number unmatched by any single cancer center.--By bringing together a network ofglobally-recognized cancer experts, we are collaborating and sharing bestpractices that address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.--Sarah Cannon Research Institute is theresearch arm of HCA Healthcare---s global cancer institute, Sarah Cannon. Focusedon advancing therapies for patients, it is one of the world---s leading clinicalresearch organizations conducting community-based clinical trials throughoutthe United States and United Kingdom. Sarah Cannon---s network of strategic sitesincludes more than 275 physicians who engage in research. The organization hasled more than 260 first-in-man clinical trials since its inception in 1993, andhas been a clinical trial leader in the majority of approved cancer therapiesover the last 10 years.--Benefits:
We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.

Summaryof Position: Supports process improvement, andinternal/external audits within the Investigative Site serving as the internalquality contact and resource for the department to support quality initiativesand projects.--Duties and Responsibilities--Duties include but are not limited to:
  • Prepares for and hosts external sponsor / IRBaudits
  • Investigates and responds to Corrective andPreventive Action (CAPA) requests in collaboration with Clinical Operations andCQA.
  • Works with Clinical Operations to obtainevidence of deliverables and facilitates effectiveness checks as needed toensure CAPA closure.
  • Reviews monitor letters for issue escalation andquality performance issues
  • Develops a calendar for monitoring qualityindicators/quality check (QC) and provides routine reporting of variances tothe appropriate Clinical Quality Assurance (CQA) staff and operationalleadership
  • Identifies areas of quality deficiency ensuringescalation to operational leadership and communication with appropriate CQAstaff.
  • Coordinates and facilitates quality reviewmeetings with appropriate CQA staff and operational leadership
  • Communicates with monitors and auditors asneeded
  • Monitors, coordinates, and assists withprocedure modification for quality management as required.
  • Assists in development and modification ofdepartmental work instructions and collaborates with appropriate CQA staff toensure alignment with SOPs
  • Educates research staff in quality improvementmethods
  • Assists research staff in maintaining FDAcompliance
  • Performs related work as required
    Qualifications MinimumQualifications--Education:Minimum Required: AssociateDegree (2 year program)Preferred: Bachelor---s College Degree (4 year program)--Experience:MinimumRequired:
    • Experience in clinical research ideally workingin a clinical quality department or site
    • Excellent written and verbal communicationskills
    • Organization skills and ability to multi-taskvarious responsibilities Preferred:
      • Professional Research Certification: ACRP orSoCRA certification
      • Qualityassurance, quality management or quality auditing experience in a clinicalresearch organization or sponsoring company
      • Experiencein 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 toapply? We promptly review all applications. If you are highly qualified youwill hear from one of our recruiters. We are actively interviewing so applytoday.
        We are an equal opportunityemployer and value diversity at our company. We do not discriminate on thebasis of race, religion, color, national origin, gender, sexual orientation,age, marital status, veteran status, or disability status.

        Company Description:

        HCA Healthcare is a collaborative healthcare network, driven by physicians, nurses and colleagues helping each other champion the practice of medicine to give people a healthier tomorrow. With a comprehensive network of more than 270,000 people across approximately 1,800 care facilities, our scale enables us to deliver great outcomes for our patients, provide superior nursing care and be a preferred place for physicians to practice medicine. We never stop in our pursuit of insights and care advances based on the knowledge and data we gain from approximately 30 million patient encounters a year. Every day, we raise the bar to improve the way healthcare is delivered, not just in our facilities, but everywhere. We---re committed to improving more lives in more ways, and above all else, we are committed to the care and improvement of human life.