Responsibilities - 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 based on study progress, changes, and risks.
- Support study teams in identification, investigation, and remediation of quality issues, including root cause, corrective and preventive action, and effectiveness check discussions.
- Provide oversight, transparency, and tracking of quality issues for assigned studies and when required, provide metrics to leadership.
- Actively participate in key internal project team meetings and facilitate quality discussions.
- Provide expert quality advice to study teams and site leadership, responding to consultancy requests for best practices, process optimization, and regulatory requirements.
- Partner with study teams and site leadership to achieve and maintain a state of inspection readiness. Communicate with Quality Management leadership regarding readiness, risks, and gaps.
- Identify areas for continuous improvement of the Quality Management System by sharing feedback on processes and participating in process improvement initiatives as requested.
- Communicate regularly within QM team to share lessons learned.
- Support study teams and site leadership with study-specific training requirements and compliance oversight.
- Additional duties as assigned by management.
Required Skills PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS: - Work is performed remotely from the employee's home office.
- Local travel (up to 60 miles) may be required up to 50% depending on location.
- National travel up to 20%
- Daily computer use
- Ability to drive and daily availability of an automobile.
MINIMUM REQUIREMENTS: Education: Bachelor's degree or commensurate experience.
Experience: Minimum 2 years' experience in clinical research quality support; exceptions may apply to extraordinary candidates with clinical operations background and strong quality and compliance mindset. Strong understanding of research activities and processes at research sites.
Preferred Skills Knowledge and Skills: - Thorough understanding of root cause analysis and corrective and preventive action processes.
- Collaborative and supportive team player with ability to lead cross-functional initiatives while fostering relationships between quality and operations.
- Ability to prioritize work based on deadlines, priorities, and study team schedules.
- Thorough knowledge of GCP guidelines and research regulations.
- Proactive, flexible, and driven mindset, able to keep yourself and others on task.
- Extremely organized with a high attention to detail.
- Excellent oral and written communication skills.
- Excellent computer skills to include Office365 products.
- Strong problem solving, risk assessment and impact analysis abilities.
- Ability to think independently and influence when appropriate.
Schedule/Shift Shift: Monday-Friday day shift (40 hours per week)
Location: Onsite, Denver, CO
