Title: Project Quality and Risk Lead
Summary:
Are you a clinical professional looking to join a new team of like-minded individuals seeking to help patients across the country? My client supports clinical trails by providing both sponsors and CROs with a single point of contact, eliminating multiple budgets and contracts across multiple sites. My client works to consolidate all activities throughout the entire lifecycle of the study, allowing for a streamlined process and efficient study. This role will act as the main project quality contact and support for study teams, guiding quality and risk oversight from study award to close. If this sounds like something you would be interested in, please keep reading!
The Project Quality and Risk Lead will:
- Lead study teams in risk management assessment, planning and mitigation.
- Drive risk management activities and tracking, ensuring risk oversight and activities are updated as appropriate.
- Support study teams in identification, investigation and remediation of quality issues, including root cause, CAPA and effectiveness check discussions.
- Communicate with Quality Management leadership regarding readiness, risks and gaps.
- Identify areas for continuous improvement of QMS.
- Provide oversight, transparency and tracking of quality issues for assigned studies.
The Project Quality and Risk Lead should have the following experience:
- Bachelor's Degree in a related field or commensurate experience.
- At least 2 years in clinical research quality support.
- Strong understanding of research activities and processes at research sites.
- Thorough understanding of root cause analysis and CAPA.
- Working knowledge of GCP guidelines and research regulations.
- Work collaboratively and cross-functionally with other teams.
*This position is being offered in Orlando, FL and Miami, FL as an on-site, permanent position*
If this sounds like something that you would be a great fit for, please do not hesitate to apply!
