Quality and Risk Lead

Purpose

Main project quality contact and support for study teams, guiding quality and risk oversight from study award to close. This includes, but is not limited to, leading study teams in risk management identification and mitigation activities, conducting risk-based study milestone reviews, assisting study teams with quality issue identification and management, and collaborating with site teams and leadership to ensure inspection readiness. This role will support Quality Management leadership by providing regular quality oversight communications, contributing to company quality oversight objectives as established within the Quality Management System. Work with Vice President, Support Services, Senior Director of Project Quality, Director of Process Quality, site leads and other managers to define and create procedures, train, and implement Flourish Research standards into clinical studies.

Essential Job Functions

• 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

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.

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

Physical Requirements and 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

Pay

$85,000-$95,000 per year (depending on experience)

Schedule

Monday-Friday day shift (40 hours per week), onsite in Denver, CO

Benefits

• Health, dental, and vision insurance plans
• 401(k) with a 100% employer match on the first 4% of employee contributions
• Tuition reimbursement
• Parental leave
• Employee referral program
• Employee assistance program
• Life insurance
• Disability insurance
• Generous PTO plan covering vacation, sick, personal days and 8 paid holidays