RBQM Operations Associate

CTI

United States

Hybrid

USD 60,000 - 90,000

Full time

3 days ago

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Benefits offered by this job

Hybrid work from home opportunities

Paid parental leave

Health benefits and 401(k) matching

Job summary

CTI Clinical Trial and Consulting Services in the United States is seeking an entry to mid-level RBQM coordinator to support the execution, operationalization, and continuous improvement of CTI’s Risk-Based Quality Management framework across the clinical trial portfolio. The role focuses on practical RBQM execution under guidance from Clinical Project Management and RBQM leadership.

You will coordinate IQRMP development and maintenance, support RACT/RMP/IDRP activities, facilitate

Qualifications

Bachelor’s degree in health, life sciences, or related field, or equivalent.
At least 2 years in clinical research, data management or quality.
Basic understanding of clinical trial operations and GCP.
Experience with RBQM concepts including KRIs and risk assessments.
Familiarity with ICH E6(R2/R3) guidelines.
Experience with clinical trial systems (EDC, RBQM tools).
Prior experience supporting risk review processes and data review.

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 activities and risk review preparation and meetings.