Quality and Risk Lead

Purpose

Serves as the main quality contact and support for site management and study teams, guiding quality and risk oversight within an oncology clinical research setting. Leads site management and study teams in risk management identification and mitigation activities, conducts risk-based study milestone reviews, assists study teams with quality issue identification and management, supports site team with audit preparation and audit activities, and collaborates with site teams and leadership to ensure inspection readiness.

Essential Job Functions

• Lead site management and study teams in risk management assessment, planning, and mitigation, including attention to oncology-specific risk factors such as dose-limiting toxicities, SAE rates, complex eligibility criteria, and risks of combination therapy or novel oncology agents.
• Track and report metrics for site leadership and provide support for risk mitigation activities.
• 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 provide metrics to leadership.
• Actively participate in key internal project team meetings and facilitate quality discussions.
• Support site staff and Process Quality in sponsor audits/preparation.
• Provide expert quality advice to study teams and site leadership on best practices, process optimization, and regulatory requirements.
• Partner with study teams and site leadership to achieve and maintain inspection readiness, including awareness of FDA Oncology Center of Excellence expectations and ICH E6(R3) considerations.
• Identify areas for continuous improvement of the Quality Management System.
• Communicate regularly within the Quality Management team to share lessons learned.

Physical Requirements and Environmental Factors

• Work is performed in an oncology clinical research site; may include exposure to oncology treatment environments.
• Travel may be required up to 10% depending on location.
• 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 oncology clinical research quality support. Strong understanding of research activities and processes at research sites, particularly within oncology or hematology/oncology therapeutic areas.

Knowledge and Skills

• Thorough understanding of quality issue management including root cause analysis and corrective and preventive action processes.
• Thorough understanding of clinical trial processes, including oncology-specific processes such as dose escalation/de-escalation designs (e.g., 3+3, BOIN), response assessment criteria (RECIST, iRECIST), and oncology biomarker/companion diagnostic workflows.
• Thorough knowledge of oncology clinical trial site operations, including common oncology patient safety considerations, investigational oncology product handling requirements, and heightened ethical and regulatory obligations.
• General understanding of clinical trial auditing processes.
• Collaborative and supportive team player with ability to lead cross-functional initiatives.
• Ability to prioritize work based on deadlines, priorities, and study team schedules.
• Thorough knowledge of GCP guidelines and research regulations, including NCI guidelines, FDA oncology drug approval frameworks, CTCAE grading standards, and expedited safety reporting requirements.
• Proactive, flexible, and driven mindset.
• 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.