Clinical Research Quality and Training Coordinator

Job Summary
The Quality and Training Coordinator at our clinical research site network develops, implements, and evaluates training programs while monitoring quality standards to ensure compliance, consistency, and operational excellence. This role collaborates with managers and team members to identify skill gaps, improve processes, and support employee development.

Key Responsibilities

• Design, develop, and deliver onboarding and ongoing training programs for clinical research personnel.
• Maintain training materials, manuals, and standard operating procedures (SOPs).
• Support onboarding of new clinical research trials to ensure operational readiness and manage any risk associated with each clinical trial.
• Collaborate with study monitors through regular review of monitoring follow up letters and individual discussions.
• Monitor quality metrics and identify trends, risks, and improvement opportunities.
• Evaluate employee performance through quality audits, observations, and assessments.
• Conduct coaching sessions and provide constructive performance feedback.
• Ensure compliance with company policies, regulatory requirements, and industry standards.
• Analyze training effectiveness using performance data and employee feedback.
• Coordinate training schedules, workshops, and refresher courses.
• Collaborate with department managers to develop performance improvement plans.
• Investigate quality issues, manage MPDs and recommend corrective and preventive actions (CAPA).
• Support continuous improvement initiatives and process optimization.
• Manage external audits with regulators and sponsors

Qualifications

• Bachelor's degree in Business Administration, Education, Human Resources, Quality Management, or a related field (preferred).
• 2–5 years of experience in training, quality assurance, learning and development, or operations in clinical research.
• Experience developing and facilitating training programs.
• Knowledge of quality management principles and auditing techniques.
• Proficiency in Microsoft Office Suite, particularly Excel, PowerPoint, and Word.

Required Skills

• Excellent communication and presentation skills.
• Strong coaching and mentoring abilities.
• Analytical and problem-solving skills.
• Attention to detail and organizational skills.
• Ability to manage multiple priorities and deadlines.
• Strong interpersonal and relationship-building skills.
• Data analysis and reporting skills.
• Process improvement and continuous improvement mindset.
• Time management and project coordination.
• Ability to work independently and collaboratively.
• Health Canada Division 5 Guidelines & GCP knowledge

Working Conditions

• Capability to travel and work across multiple clinical trial sites.
• May require flexible hours to accommodate different shifts.