Associate Director Of Clinical Quality Assurance

Overview

• Lead clinical quality assurance initiatives, ensuring adherence to GCP regulations and fostering excellence in clinical trial practices.
• Develop and implement strategies to maintain compliance and enhance operational quality standards.
• Collaborate with cross-functional teams to drive continuous improvement in clinical quality assurance processes.
• Provide expert guidance and training on GCP compliance to clinical investigators and staff.
• Support regulatory inspections, ensuring clinical programs are audit-ready and compliant.
• Manage audit schedules, tracking systems, and metrics to monitor quality assurance activities effectively.
• Contribute to the development of corrective action plans, addressing audit findings proactively.
• Engage in a hybrid work model, combining onsite collaboration with remote flexibility.

Key Responsibilities & Duties

• Conduct and oversee GCP audits of clinical sites, vendors, and internal systems to ensure compliance.
• Develop and execute study-specific audit plans, coordinating with auditors and clinical teams.
• Review audit reports, ensuring alignment with SOPs and regulatory standards.
• Collaborate with clinical teams to resolve audit findings and implement quality improvements.
• Provide training and mentorship on GCP compliance and regulatory requirements.
• Assist in regulatory inspections, preparing documentation and ensuring readiness.
• Maintain tracking databases for audit activities, providing metrics and insights to management.
• Ensure vendor performance aligns with GCP standards, addressing compliance issues effectively.

Job Requirements

• Bachelor’s degree in Nursing, Health Science, or a related field is required.
• Minimum of 10 years of experience in GCP auditing or compliance roles.
• Proficiency in US and ICH GCP regulations and guidelines is essential.
• Knowledge of clinical safety and trial management systems such as ARISg and TrialWorks.
• Strong interpersonal, oral, and written communication skills to engage effectively.
• Ability to manage competing deadlines and perform under pressure.
• Experience with tracking databases like TrackWise and LIMS is preferred.
• Demonstrated ability to work independently and collaboratively within team environments.