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About the Role
This entry to mid-level role supports the execution, operationalization, sustainability, and continuous improvement of CTI’s Risk-Based Quality Management framework. It focuses on operational execution, coordinating quality and risk management activities, and ensuring consistent RBQM execution across studies.
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
- Assist the Director, RBQM with strategic, operational, and client-facing initiatives
- 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
Requirements
- Bachelor’s degree in health, life sciences, or related field, or equivalent combination of education and experience
- At least 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 reviewing clinical data, reports, or study metrics preferred
- 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)
- Prior experience supporting risk review processes, data review, or quality oversight activities
Skills
- Risk-Based Quality Management (RBQM)
- Integrated Quality and Risk Management Plans (IQRMPs)
- RACT
- RMP
- IDRP
- Protocol review
- Risk management
- Documentation management
- Centralized monitoring
- Key Risk Indicators (KRIs)
- Quality Thresholds (QTLs)
- Clinical trial systems (EDC, BI RBQM tools, CluePoints, Medidata)
- ICH E6(R2/R3) guidelines
- Good Clinical Practice (GCP)
Location
- Remote
- Hybrid
Work Type
- Full-time
Experience Level
- Entry to mid-level
- At least 2 years of experience
Education Level
- Bachelor’s degree in health, life sciences, or related field, or equivalent combination of education and experience
Benefits
- Generous health benefits
- Vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- Tuition reimbursement
- Dedicated training department
About the Company
- CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
- CTI assists clinical research throughout the lifecycle of development, from drug concept to commercialization.
- CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
Equal Opportunity
- We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave.
- We encourage care for the world around us through our unique CTI Cares program.
- We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.