RBQM Operations Specialist — Risk-Based Quality Management

CTI; Covington (KY); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health benefits

Hybrid work opportunities

Tuition reimbursement

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services in the United States seeks an entry to mid-level RBQM coordinator to support the Risk-Based Quality Management framework across the clinical trial portfolio. You will coordinate IQRMPs, RACT/RMP/IDRP activities, and risk review meetings under RBQM leadership.

This role emphasizes operational execution, documentation governance, and collaboration with data management, biostatistics, and medical monitoring, using tools like CluePoints and Medidata.

Qualifications

• Bachelor’s degree in health, life sciences, or related field or equivalent experience.
• At least 2 years in clinical research, data management, monitoring, quality, or similar role.
• Basic understanding of clinical trial operations and GCP.
• Experience with RBQM concepts, KRIs and centralized monitoring.
• Familiarity with ICH E6(R2/R3) guidelines and trial systems.

Responsibilities

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs).
• Support and coordinate RACT, RMP, and IDRP activities, including protocol review.
• Facilitate cross-functional risk review meetings and track action items.
• Maintain RBQM documentation, trackers, logs, and SharePoint resources.
• Coordinate RBQM trial-specific activities and ensure team accountability.
• Support centralized monitoring and risk review preparation and meetings.
• Partner with PM, Data Management, Quality, Medical Monitoring, Biostatistics.
• Utilize RBQM platforms to support monitoring and documentation.
• Contribute to process improvement initiatives related to RBQM execution.

Skills

RBQM concepts

Quality monitoring

Cross-functional

Data management

Regulatory knowledge

Education

Bachelor’s degree in health, life sciences, or related field

Tools

CluePoints

Medidata

EDC systems

Job description

CTI Clinical Trial and Consulting Services in the United States seeks an entry to mid-level RBQM coordinator to support the Risk-Based Quality Management framework across the clinical trial portfolio. You will coordinate IQRMPs, RACT/RMP/IDRP activities, and risk review meetings under RBQM leadership.

This role emphasizes operational execution, documentation governance, and collaboration with data management, biostatistics, and medical monitoring, using tools like CluePoints and Medidata.