Research Associate – ICRA

• Manage site start-up activities from feasibility and qualification through site activation
• Build working relationships with investigators and site staff as the primary contact for assigned sites
• Prepare, review, negotiate, and execute regulatory and site documents, including confidentiality disclosure agreements, informed consent forms, translations, and amendments
• Coordinate submissions and approvals with Institutional Review Boards, Independent Ethics Committees, Ministries of Health, and Regulatory Authorities
• Develop and track site activation strategies, timelines, and regulatory plans to support project milestones
• Maintain accurate, high-quality documentation in clinical trial management, electronic trial master file, and trial master file systems
• Identify, resolve, or escalate site issues and risks related to activation, recruitment, compliance, training, and data quality
• Support sites with study system access, training requirements, and readiness activities
• Ensure assigned sites remain audit-ready and inspection-ready throughout the study lifecycle
• Maintain compliance with Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel standard operating procedures
• Collaborate across functions to achieve project milestones and deliverables, communicating progress, risks, and issues

• Strong clinical research and study start-up experience
• Excellent problem-solving, communication, presentation, and stakeholder management skills
• Ability to work independently, prioritize multiple tasks, and make sound decisions in ambiguous situations
• Experience working in global, matrix, and multicultural environments
• High attention to detail and strong quality focus
• Commitment to achieving project timelines
• Strong knowledge of clinical trial management systems, electronic trial master file systems, trial master file processes, and Microsoft Office tools
• Knowledge of International Council for Harmonization Good Clinical Practice guidelines, local regulatory requirements, sponsor requirements, and clinical trial start-up processes
• Excellent oral and written English skills
• Strong communication, organization, presentation, stakeholder management, and problem-solving skills

• Home-based role with flexibility that working from home offers
• Dedicated line managers and a strongly connected team
• Opportunities to deepen expertise across global study start-up and regulatory operations
• Flexibility and growth opportunities