Quality Assurance Specialist, Clinical Research - Chicago, United States - Cook County Health & Hospitals System

Cook County Health & Hospitals System

Verified Company

Chicago, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

QUALITY ASSURANCE SPECIALIST, CLINICAL RESEARCH

Job Number:
**
Job Posting: Apr 9, 2024, 6:57:12 PM
Closing Date: Apr 23, 2024, 11:59:00 PM

Full-time
Shift Start Time: 8:30 A

M
Shift End Time:
4:30 P.M.

Collective Bargaining Unit:
None

Posting Salary:
Competitive Salary

Organization:
Health and Hospital Systems

Job Title:
Quality Assurance Specialist, Clinical Research

Department:
Research & Clinical Trials

This position is exempt from Career Service under the CCH Personnel Rules.

Job Summary

The Quality Assurance Specialist, Clinical Research is responsible for identifying and analyzing clinical research key performance metrics, facilitating performance improvement activities, and ensuring compliance with all Federal, Local, Institution Review and Good Clinical Practice (GCP) standards.

The Clinical Research Quality Assurance Specialist will have direct involvement in improving the quality and compliance of clinical research activities through system risk assessments, auditing programs, and benchmarking reports of identified key performance indicators.

Serves as a resource on quality assurance and clinical research, clinical trial monitoring and auditing procedures, and regulatory standards across Cook County Health (CCH).

Typical Duties

Manages quality assurance activities across CCH clinical research operations
Analyzes and measures collected data, such as, quality assurance data and customer feedback data, as part of monitoring for continuous improvement. Designs, plans, and delegates new clinical research initiatives
Implements and ensures efficient processes for research activities by monitoring effectiveness and fiscal integrity
Provides strategic leadership and ensures alignment of policies and procedures to technology systems i.e., bioinformatics, data integration, EHR data extraction
Reviews and updates departments policies and procedures, including protecting the privacy of research participants
Understands and maintains current knowledge of federal and local standards and regulations. Communicates regulatory changes, updates procedures according to best practices
Provides current and accurate research compliance information and resources to the research community. Evaluates research compliance by planning and performing monitoring activities (i.e., routine and forcause audits) to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), etc.) and Conference on Harmonization and Good Clinical Practices (ICH-GCP)
Investigates research compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings
Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn. Exercises appropriate judgment in evaluating audit findings, develops Corrective and Preventive Action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner. Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner
Collects data on audit findings, prepares comprehensive reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives. Presents data, trends, and risk assessments to the Institutional Review Board (IRB) and the Office of Research Integrity & Compliance
Performs comprehensive clinical research records reviews to identify quality of research documentation and compliance, risks, and compile inspection reports
Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution
Drafts the clinical research monitoring and auditing plans. Reports on results and trends based on findings for clinical research compliance
Reviews and present audit findings
Acts as a liaison to research leadership to support managing research portfolios
Assists in the management of external audits by regulatory agencies or business partners. Provides information and services to help research with FDA inspection readiness
Facilitates development of quality metrics, guides development of clinical research dashboards and assists in tracking and trending data
Analyzes trends of performance metrics, identifies opportunities for improvement, and develops action plans
Collaborates with and trains staff to implement monitoring and measurement tools, and data analysis techniques
Facilitates quality efforts and coaches others in the development of performance improvement activities with a