HCA, Hospital Corporation of America Senior Clinical Quality Consultant - Work From Home in Nashville, Tennessee
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%) Competencies Knowledge: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 Skills: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 Abilities:An underlying, enduring trait useful for performing duties * Customer-focused * Relationship building * Analytical * Organized, ability to prioritize * Detail-oriented and meticulous
_Education:_ Minimum Required:Bachelor’s College Degree (4 year program) Preferred:Master’s Degree (1-2 year program)
_Experience:_ Minimum Required: * Quality assurance experience in a clinical research organization or sponsoring company * Quality Assurance consulting and auditing experience in a GxP environment * Experience managing study timelines, deliverables, and/or vendors in a client facing role * Experience in clinical quality auditing, outcomes and medical writing Preferred: * 7 years’ experience in Healthcare or sponsored research or other science-related field * Quality Assurance consulting and auditing experience in a GxP environment * Experience with Investigator Initiated Trials (IIT)– preferred * Experience in a clinical trial environment * Demonstrated leadership skills * Prior experience mentoring and/or training less senior team members
*If interested in advancing your career with a growing leader in clinical research please apply today!*
Job: *Case Management
Title: Senior Clinical Quality Consultant - Work From Home
Location: Tennessee-Nashville-Sarah Cannon Clinical Operations
Requisition ID: 25320-4839