Quality and Risk Lead

Flourish Research•Denver, CO

3d•$85,000 - $95,000•Onsite

About The Position

Flourish Research is a progressive and diversified clinical trial organization with strong capabilities across multiple therapeutic areas. Valkyrie Clinical Trials (VCT), a Flourish Research Company, is a leading Oncology multi-site clinical research network. VCT approaches clinical research with a deep sense of humanity, compassion, and sincere kindness. VCT was founded by leading Clinical Oncologist, Dr. David Berz, and has multiple sites spanning California and Denver, Colorado. We are actively hiring a Quality Risk Lead to support our Valkyrie Clinical Trials Denver, Colorado site. The purpose of this role is to serve as the main project quality contact and support for study teams, guiding quality and risk oversight from study award to close. This includes 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 and contributing to company quality oversight objectives as established within the Quality Management System. The role will also work with various leadership members to define and create procedures, train, and implement Flourish Research standards into clinical studies.

Requirements

Bachelor’s degree or commensurate 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.
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.

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.