RBQM Coordinator – Risk-Based Quality Management (Hybrid)

CTI Clinical Trial and Consulting Services; Covington (KY); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Vacation packages

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services is seeking an entry- to mid-level RBQM operations professional to support the Risk-Based Quality Management framework across our clinical trial portfolio. You will coordinate IQRMP activities, manage RACT/RMP/IDRP tasks, and help maintain RBQM documentation under leadership guidance.

Work with Clinical Project Management and functional partners to drive proactive risk oversight, issue resolution, and documentation governance, ensuring consistent RBQM

Qualifications

• Minimum 2 years of experience in clinical research, data management, monitoring, quality, or similar role in a CRO, pharmaceutical, or healthcare setting.
• Basic understanding of clinical trial operations and Good Clinical Practice (GCP).
• Experience with RBQM concepts, including KRIs, risk assessments, or centralized monitoring.
• Familiarity with ICH E6(R2/R3) guidelines.
• Experience working with clinical trial systems (e.g., EDC, RBQM tools such as CluePoints or Medidata).

Responsibilities

• Coordinate development and maintenance of Integrated Quality and Risk Management Plans (IQRMPs).
• Support and coordinate RACT, RMP, and IDRP activities, including protocol review and assessment.
• Facilitate cross-functional risk review meetings and ensure action items are tracked to completion.
• Maintain RBQM documentation, trackers, logs, templates, and SharePoint resources.
• Coordinate RBQM trial specific activities, and ensure trial team accountability.
• Support routine centralized monitoring (KRI/QTL review) activities and risk review preparation and meetings.
• Partner with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams to support RBQM execution.
• Utilize RBQM platforms and systems (e.g., BI RBQM tools, CluePoints, Medidata) to support monitoring and documentation activities.
• Contribute to process improvement initiatives related to RBQM execution, tools, and documentation.

Skills

RBQM concepts

KRIs & risk assessment

Cross-functional collaboration

Clinical trial data experience

Education

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

Tools

CluePoints

Medidata

EDC

Job description

CTI Clinical Trial and Consulting Services is seeking an entry- to mid-level RBQM operations professional to support the Risk-Based Quality Management framework across our clinical trial portfolio. You will coordinate IQRMP activities, manage RACT/RMP/IDRP tasks, and help maintain RBQM documentation under leadership guidance.

Work with Clinical Project Management and functional partners to drive proactive risk oversight, issue resolution, and documentation governance, ensuring consistent RBQM