Clinical Quality Specialist Job Description
Clinical quality specialist
provides quality system management assistance within the regulations of clinical studies and quality standards, specifically: 21 CFR Part 312, 21 CFR Part 11, ICH E6 and ISO standards.
Clinical Quality Specialist Duties & Responsibilities
To write an effective clinical quality specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical quality specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Demonstrates the ability to set appropriate priorities
Recognizes how absence impacts the functioning of the healthcare team and strives to minimize this effect
When requested, is willing to adjust personal schedule in order to complete workload when necessary
Attends educational offerings as needed to promote continuous learning and support to department
Exhibits a thorough knowledge of clinical documentation issues, MS-DRG assignments, severity of illness (CC’s and MCC’s), Present on admission (POA’s), Hospital Acquired Conditions (HACs) and clinical conditions and treatments
Reviews and applies analytical skills to designated patient population medical record documentation to assess the level of documentation accuracy and completeness
Assists to identify the most appropriate principal diagnosis and co-morbidities to accurately reflect several of illness in compliance
Assigns and monitors DRG assignment to appropriately reflect the accurate severity at admission and throughout hospital stay
Addresses missing, conflicting, or incomplete documentation issues by following up with providers when needed
Facilitates modification to the clinical documentation supporting the clinical picture/level of severity rendered to all patients at the hospital
Clinical Quality Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Quality Specialist
List any licenses or certifications required by the position: CDN, CNN, OASIS, CP, CLIA, AHIMA, GCP, CPHQ, ACRP, IHI
Education for Clinical Quality Specialist
Typically a job would require a certain level of education.
Employers hiring for the clinical quality specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Nursing, Education, Healthcare, Health, Medical, Graduate, Health Care, Business, English, Engineering
Skills for Clinical Quality Specialist
Desired skills for clinical quality specialist include:
NCQA
ISO 14971
Medicare
Medicare and TDI regulatory standards
21 CFR 803
GCP regulations/ guidelines
Governing and regulatory agency requirements
Government health care program
HEDIS
Managed care industry
Desired experience for clinical quality specialist includes:
Assesses documentation for areas of needed improvement and addresses with provider in a timely manner
Collaborates with HIM staff to enhance their understanding of documentation resulting in appropriately assigning the DRG representing the patient severity of illness, presence of complications
Assess needs of providers and creates collaborative action plans for improvement where needed
Adjusts schedule and approach to best meet the needs of the providers
Communicates timely and cooperatively with HIM staff on needed feedback
Develops and provides educational sessions for providers when appropriate
Clinical Quality Specialist Examples
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Clinical Quality Specialist Job Description
Job Description Example
Our innovative and growing company is looking for a clinical quality specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical quality specialist
- Committee Meetings – Prepares for and participates in meetings
- Conducts monthly internal audits and reporting
- To oversee testing, reporting, and evaluation of proficiency testing material
- Maintain current SOPs for processes
- To assist in maintaining current laboratory licenses and certificates
- To assist in maintaining competency assessments and documentation
- Compiles quality data to capture metrics
- Maintain up-to-date information on updates and changes to national and international regulations related to company business objectives
- Performs other quality related functions as required
- Perform as a Liaison, under the direction of the VP Global Quality & Compliance, for client audits of Novella, including both general qualification audits project specific audits
Qualifications for clinical quality specialist
- Advanced computer skills in MS office systems
- Strong database development & systems
- Current CRA certification or CCRP
- Requires a 4 year degree in Laboratory Science, Biology, or Chemistry
- Prior laboratory experience of 3 or more years preferred
- Must have knowledge of regulatory requirements for laboratory operations to include CLIA, GLP, GCP, GMP, and HIPAA
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Clinical Quality Specialist Job Description
Job Description Example
Our company is growing rapidly and is looking for a clinical quality specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical quality specialist
- Perform a review of Histology study materials to ensure that the work is accurately reflected in the raw data
- Review proposed validation plans to ensure compliance with the applicable validation SOP
- Review validation data to ensure accuracy of data and compliance with the proposed plan
- Review and understands applicable sections of sponsor protocols for GLP studies in order to perform inspections with competence
- Periodically submit written status reports on GLP studies to management and the Study Director as required
- Perform and/or assists with regulated or quality client audits, and FDA inspections
- Perform and documents internal facility audits and in-phase study inspections
- Determine that no deviations from standard operating procedures or approved protocols were made without proper authorization and documentation
- Maintain copies of client protocols for regulated studies as required
- For GLP studies, prepare and sign Quality Assurance Statements
Qualifications for clinical quality specialist
- Demonstrated ability to manage projects and work independently to develop creative solutions to ongoing complex issues/challenges
- Strong computer skills in Microsoft systems, including Word, Excel and Power Point
- Certification as CCRP, CTA, CRC
- Repetitive Motion, Near Acuity, Copying
- Minimum of 3 years clinical experience in an acute care setting
- Responsible for travel, Financial Administration as needed
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Clinical Quality Specialist Job Description
Job Description Example
Our growing company is hiring for a clinical quality specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical quality specialist
- Collaborate directly with the head of Medical Affairs and with the Medical Affairs team
- Detect and analyze problems in the result output of high throughput sequencing assays
- Perform project management of clinical collaborative studies
- Oversee the status of ongoing clinical research projects
- Perform cross-functional communication with other teams, including computational biology, information technology
- Help prepare conference abstracts, manuscripts and grant applications
- Evaluate audit findings to determine severity, , critical, major or minor, and provide advice and guidance in developing corrective and preventative course of action to resolve audit findings
- Objective evidence to determine conformity to requirements listed above, including ranking the levels of
- Participation in the investigation of deviations in the production (lead investigator) central contact persons of the supervisors in the production for quality issues
- Organizes and takes responsibility for Quality Assurance in all activities related to clinical vaccines
Qualifications for clinical quality specialist
- Fluent in English, knowledge of other languages (e.g., German) a plus but not required
- Experience in Operational support role and relevant ad-ditional career training
- Broad understanding of Health Authority expectations in the areas of Pharma Development
- Training and curricula development experience desira-ble, including oversight and administration of validated electronic systems such as LMS or other quality man-agement systems
- In depth knowledge and working experience with com-mon computer software programs, MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)
- Bachelor's Degree, scientific discipline preferred and 5 years of previous related Clincial Monitoring, Quality Assurance/Control, or Regulatory Compliance experience
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Clinical Quality Specialist Job Description
Job Description Example
Our company is looking for a clinical quality specialist. 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 specialist
- Ensures all GMP productions are in line with product development evaluations and regulatory
- Maintain compliance with federal and state clinical laboratory requirements including CLIA accreditation and required out of state licensing
- Assist in audits of internal systems such as external and internal assessments and supports customer audits and requests for proficiency testing documentation and results
- Responsible for proficiency testing programs both internal and external
- Help ensure that quality inspections are thorough and
- Maintain up to date information on updates and changes to national and international regulations related to company business
- Performs other quality related functions as
Qualifications for clinical quality specialist
- Broad working knowledge of cGMP regulations
- Demonstrated experience in quality systems, project management and regulatory compliance
- Experience with major LIS systems required
- Ability to write reports containing technical information
- Must have well developed computer skills, including word-processing, spreadsheets, and e-mail
- Ability to investigate, analyze information/data and draw conclusions
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Clinical Quality Specialist Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of clinical quality specialist. 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 specialist
- Act as QA contact for all activities related to new clinical product introductions, including but not limited to change control review and approval
- Provide guidance and direction to Quality, Clinical Supply Chain Management, Production, and Warehouse/ Distribution with regards to compliance with quality policies, standards and procedures
- Act as QA contact for Non-conformances and Corrective and Preventive Actions (CAPA)
- Participate in audits (internal, external, corporate) and in the implementation of audit commitments
- Participate/lead in various improvement efforts and projects including (new) product launch teams
- May act as an advisor on clinical quality assurance issues regarding various aspects of the clinical study phases
- Review and approve Clinical Study specific documents (Protocols, Informed consents, ) with regards to inclusion of local (Latin America and Canadian) regulatory requirements
- May provide consultation to CAPA owners to facilitate identifying root cause and development of appropriate action plans
- May partner with Clinical Quality Training Specialists to facilitate Good Clinical Practices (GCP) training for Medtronic personnel
- May assist with department SOP/compliance training for Medtronic personnel
Qualifications for clinical quality specialist
- Ability to develop and present educational programs
- Must be flexible, detail oriented, accurate and able to work in a team environment
- Must be willing to work around hazardous chemicals, and biohazardous material
- Must have a background demonstrating the ability to develop and maintain positive working relationships with physicians, employees, peers and organizational leaders
- Experience working in a laboratory environment regulated per FDA GLP 21 CFR part 58 preferred
- Knowledge of FDA GLP 21 CFR par 58