Clinical Quality Job Description
Clinical quality
provides leadership and operational oversight in the development and implementation of strategies, systems, programs and processes, as related to quality care management, and utilization management, which support accreditation and regulatory compliance on all product lines (NCQA, HEDIS, CMS, STARs, States; MA, RI, NH, ME, CT).
Clinical Quality Duties & Responsibilities
To write an effective clinical quality job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical quality job description templates that you can modify and use.
Sample responsibilities for this position include:
Enters chart review data on the excel sheet for each chart reviewed
Participation in the annual HEDIS and QARR hybrid medical record review project
Leads/promotes leveraging of audit/inspection results to effect sustained improvement/correction/compliance through robust root cause analysis, CAPA implementation/tracking, and reporting/communication of lessons learned to broader organization
Ensures compliance with current global regulatory standards internal standards, processes and procedures
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, ) as needed
Maintain the control and ongoing monitoring of quality and reliability quality reporting mechanisms and management tools
Complete SNF remote chart review when available, CareOne chart review of initial note when available
Serve as the subject matter expert in GCP, develop standards and promote collaboration with Clinical Development and CRO to design and implement risk-based GCP quality systems and processes
Formulate GCP compliance strategy and provide advice for all FivePrime studies and programs
Develop and implement audit strategies for each clinical program
Clinical Quality Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Quality
List any licenses or certifications required by the position: CPHQ, ASQ, CPR, CQM, FEMA, BLS, SQL, MCSA, CCM, OASIS
Education for Clinical Quality
Typically a job would require a certain level of education.
Employers hiring for the clinical quality job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Nursing, Healthcare, Education, Medical, Health, Public Health, Healthcare Administration, English, Science, Business/Administration
Skills for Clinical Quality
Desired skills for clinical quality include:
Medicare market
Products and competitors
Excel
HEDIS
NCQA
Medical terminology
Managed care requirements related to clinical quality
Outlook
Multiple software programs
Anatomy and physiology
Desired experience for clinical quality includes:
Minimum of five years of experience in the development, preparation, and ongoing revision of essential clinical, safety and biometrics SOPS within Clinical Operations and QA
Knowledge of medical and statistical practice/techniques, tools and terminology
Possible travel of approximately 10-15%
Clinical degree required
Licensed/certified clinician preferred, with at least three years of experience in the ambulatory and/or hospital setting
Working knowledge of complex clinical data sources
Clinical Quality Examples
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Clinical Quality Job Description
Job Description Example
Our company is hiring for a clinical quality. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical quality
- Manage the preparation of audit reports and report audit findings to management with recommendations for resolution
- Partner with Clinical Development stakeholders, including Regulatory Affairs, Clinical Operations, Clinical Development and Pharmacovigilance/Safety, regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement
- Establish quality agreements with clinical CRO managing FivePrime’s clinical study activities
- Conduct QA reviews of project-related Clinical Development essential documents
- Play a lead role in regulatory authority inspections and interact with agencies on GCP related matters and the coordination of responses to resolve inspection findings
- Develop and facilitate GCP/GLP training for functional areas and personnel involved in the execution of clinical trials and nonclinical studies
- Participate in the evaluation, qualification and selection of CROs and other clinical and nonclinical service providers and support due diligence activities
- Serve as an expert and provide guidance on and interpretation of GCP and GLP regulations, standards and quality systems
- Performs timely and accurate abstraction and validation of clinical quality measures, as assigned (e.g., CMS/TJC Core Measures, Michigan Surgical Quality Collaborative (MSQC), Oncology Care Model (OCM)), utilizing clinical judgment and understanding of specifications and definitions related to appropriate patient populations and projects to meet requirements
- Provides clinical expertise and collaborates with multidisciplinary teams to recommend improvement opportunities, action plans, and implementation processes, including related education and follow-up in various department, unit, and/or project-specific meetings
Qualifications for clinical quality
- Experience in developing QA and Compliance SOPs and involvement in clinical trials at all phases of clinical development
- The ability to use expertise or unique knowledge and skills to contribute to the development of Company objectives and principles, and to achieve goals in creative and effective ways.In addition, he/she must be able to deal with ambiguity, bringing creative and pragmatic approaches to problem solving
- An understanding of the challenges and issues inherent in creative quality systems in a small company environment
- Directs all regional CQM activities
- Supervises QM coordinators
- Certification in a recognized professional UM/QM organization
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Clinical Quality Job Description
Job Description Example
Our company is searching for experienced candidates for the position of clinical quality. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical quality
- Works closely with Quality Analytics and H.I.T.S
- Assignment, coordination and tracking of tasks to all staff and preparation of weekly status and progress reports to the Director
- Development, implementation and updating of processes and tools that support quality review operations
- Assisting in the development and implementation of initiatives across a broad array of clinical measures and health improvement activities
- Participating in member outreach and education, as needed, to ensure members receive appropriate services
- Plans and conducts global clinical audits independently or as a team in a lead or support role
- Drive the implementation of the quality requirements within the PLS clinical team
- Lead the clinical part of the local Quality Review Board to ensure appropriate management review of all quality and compliance related topics including the review of key quality indicators (KQI)
- Ensure that applicable PLS clinical processes are implemented in line with the service scope
- Implement and lead the process to regularly review and assess KQIs at the respective CTs
Qualifications for clinical quality
- Experience working at clinical sites and the ability to use strong critical reasoning skills in analyzing and resolving clinical QA problems
- Demonstrated knowledge and understanding of applicable global regulations, quality principles and techniques and trends in the biopharmaceutical area related to small/large molecule, device, combination products, mobile medical applications
- Excellent working knowledge of Good Clinical Practice, applicable regulations, and best practices relative to the development of pharmaceutical products and/or commercial requirements
- Ability to apply compliance and risk based principles in moderate to complex situations
- Ability to understand cross functional business partners, cultural drivers
- Ability to work under minimal supervision, set challenging objectives, able to apply compliance principles in a variety of moderately complex situations
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Clinical Quality Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of clinical quality. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical quality
- Complete in-office provider audits and education as deemed appropriate pertaining to HEDIS and potential quality issues
- Complies with the Health Insurance Portability and accountability Act (HIPAA) and other state laws relating with Patient Privacy and/or Data Security shall be practiced on a daily basis
- Ensures optimum operation of the department through good attendance history and flexibility with assigned shift
- Assist with strategic and business developments through periodic evaluation of the continuum of care to identify opportunities for improved care coordination and access to appropriate care services to maximize growth and maintain excellence in clinical outcomes and cost effectiveness
- Perform periodic volume growth reports allowing planning teams to evaluate whether locations are on target to achieve their strategic goals
- Perform analytic methodologies related to quality and clinical care management topics including predictive modeling, readmissions, prevention quality indicators, avoidable admissions
- Directs, facilitates and coordinates the design and implementation of clinical quality and patient safety initiatives, programs and projects at the business unit level and system level
- Independently assesses project needs based on evidenced based best practice(s) and/or regulatory standards
- Demonstrates knowledge of the science of process improvement and provides formal and informal consultation to all members of the health care team and support staff, external customers (including students), and administrative staff in process improvement methodologies, performance measurement, sustain and spread methodologies
- Designs and delivers formal and informal education to all members of the health care team and support staff, external customers (including students), administrative staff on patient safety and clinical process improvement, performance measurement and management, change management, sustain and spread methodologies, and other key subjects critical to the support of patient safety and clinical performance improvement including external regulatory and quality agencies
Qualifications for clinical quality
- Minimum of seven years of experience in clinical QA
- Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives
- Excellent verbal and written communication skills, ability to work well in teams or independently ad able to prioritize work, manage multiple projects while maintaining quality and advocate for compliance
- Demonstrated ability to interact with colleagues and individuals at clinical sites in a diplomatic, tactful and detail oriented fashion
- Capable of leading and motivating interdepartmental teams to achieve objectives of complex scope
- Mobilize relevant colleagues and business partners when facing obstacles
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Clinical Quality Job Description
Job Description Example
Our growing company is hiring for a clinical quality. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical quality
- Interpret data for customers including leadership
- Ensure that regulatory-related project documentation is developed and organized according to standards
- Responsible and accountable for the ongoing management and maintenance of HPHC’s Quality Management Programs
- Coordination, preparation and review of regulatory submissions
- Collaborate with Legal to respond to Market Conduct Exams and other requests for information
- Support achievement of Village QIP and Five-Star goals by helping drive clinical quality improvement
- Review and analyze facility clinical metrics and other pertinent data to assess performance and overall health of the facility
- Interview facility, regional and divisional leadership to understand challenges and areas for opportunity
- Identify specific tactics and processes that can be implemented or augmented to further improvement in clinical quality
- Partner with facility and regional leadership to develop a facility specific plan to address challenges and opportunity areas identified
Qualifications for clinical quality
- Ability to gather consensus and influence colleagues, business partners, and key stakeholders across the organization
- Inspires confidence, takes calculated risks, and sets challenging objectives for self and team
- Communicate confidently with peers, clients (internal/external), and local management
- Ensures free flow of information to appropriate stakeholders
- Demonstrates accountability and actions taken
- Commitment to high standards of quality, integrity and reliability
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Clinical Quality Job Description
Job Description Example
Our growing company is hiring for a clinical quality. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical quality
- Develop an expert level understanding of the QIP and Five-Star programs
- Assist during preliminary reviews of QIP and Five-Star data to ensure all facilities receive accurate scores
- Develop executive level materials and effectively present to executive audiences
- Participate in the development and creation of training materials (e.g., job aids, presentations)
- Deliver training to various field teammates and other stakeholders with fluency and credibility, facilitating a necessary understanding of key objectives
- Effectively synthesize complex programs and details and communicate them to a wide range of stakeholders in a clear and concise manner
- Attend internal team meetings and calls to ensure alignment around objectives, assess work-product delivery and timelines
- Identifies data needs and integrates data from multiple sources to create strategic and operational reports
- Provides recommendations for end users
- Project Management.Tracks departmental and strategic performance improvement initiatives to ensure that objectives are met and recommended actions are fully implemented
Qualifications for clinical quality
- Must have a minimum of an Associate’s Degree or Technical Institution certification
- Experience with FDA and international regulations (pharmaceutical and/or device, , 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155) OR experience in Quality System regulations
- Shows longevity in employment with past employers
- 3+ years varied clinical experience in acute care inpatient setting
- 1+ year quality management, risk management, or performance improvement experience / monitoring experience
- 3+ years as a clinical leader