Job Details

Senior Clinical Quality Consultant - Work From Home

Company name
HCA Holdings, Inc

Nashville, TN

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Senior Clinical Quality Consultant - Work From Home (HCA Research Institute)

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.

**This position is a Work From Home role and you can be located anywhere in the U.S. to be eligible for this role.

Summary of Position:

Responsible for implementation of the quality assurance program, managing and performing consultant visits at investigative sites. May assist with onsite external audits and inspections, and provide routine quality support for assigned investigative sites.

Duties and Responsibilities

Duties include but are not limited to:

Develops and maintains effective relationships with investigative sites and other HCA Research Institute and Sarah Cannon support services, departments and colleagues Mentors and works closely with Clinical Quality Assurance to improve consultant performance and ensure effective outcomes with the investigative sites May conduct research site assessments, including SOP gaps analysis, site readiness to conduct clinical research, and assist operational leadership in investigative site onboarding Monitors and reviews policies and procedures in collaboration with HCA Research Institute Leadership and the investigative sites Utilizes quality tools that assess the quality indicators of study operations and assists in the creation or revision of quality tools as needed Develops a calendar for routine monitoring of quality indicators and metrics for investigator sites Prioritizes attention to quality indicators depending on severity and urgency Identifies areas of deficiency in quality and reports those deficiencies to HCA Research Institute and SC Leadership and other appropriate stakeholders Assists the investigative sites in development and modification of clinical research SOPs and Work Instructions; including reviewing any existing research specific procedures as necessary to manage the scope of work by HCA Research Institute and SC Assists with the preparation, hosting and responding to external audits and regulatory inspections Assists research staff in maintaining regulatory compliance (i.e. FDA, MHRA, EU Directive, etc.) Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership Assists and drives 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 responses to audit/regulatory observations; including development of root-cause analysis, appropriate CAPA development, and effectiveness reviews (where necessary) May communicate with monitors and auditors of clinical trials, as needed. Educates and trains staff in quality improvement methods and industry trends Performs related work as required All other duties as assigned Travel, as assigned (25-50%)



A body of information needed to perform a tasks; May be obtained through education, training or experience

(US) FDA Regulations (UK) MHRA, EU Directive ICH-GCP Guidelines Medical and clinical research terminology Pharmaceutical, biologics, and/or medical device industry Outcome research and Investigator Initiated Trials


The proficiency to perform a certain task

Professional writing and communication skills Interpersonal skills Computer skills, including MS Word, Excel, Outlook; electronic data capture systems, electronic quality management systems Problem solving skills


An underlying, enduring trait useful for performing duties

Customer-focused Relationship building Analytical Organized, ability to prioritize Detail-oriented and meticulous


Company info

HCA Holdings, Inc
Website :

Company Profile
At its founding in 1968, Nashville-based HCA was one of the nation's first hospital companies. Today, we are the nation's leading provider of healthcare services, a company comprised of locally managed facilities that includes about 165 hospitals and 115 freestanding surgery centers in 20 states and England and employing approximately 204,000 people. Approximately four to five percent of all inpatient care delivered in the country today is provided by HCA facilities. Milton Johnson serves as Chairman and Chief Executive Officer of HCA. HCA is committed to the care and improvement of human life and strives to deliver high quality, cost effective healthcare in the communities we serve. Building on the foundation provided by our Mission & Values, HCA puts patients first and works to constantly improve the care we give them by implementing measures that support our caregivers, help ensure patient safety and provide the highest possible quality. Investing in our communities is important to us. HCA typically invests about $1.5 billion annually to keep our facilities modern and up-to-date technologically and to expand and add services where needed. Focusing primarily on communities where the company is a leading healthcare provider, HCA selectively adds new facilities in order to better serve our communities. And because two HCA founders were physicians, we value highly the strong relationships we've created with local physicians. We endeavor to provide them with a wide array of services and modern facilities in order to help them deliver the best possible care.

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