Clinical Research Associate

Roles & Responsibilities
• Perform and coordinate all aspects of clinical monitoring and site management activities
• Conduct remote and onsite monitoring visits to ensure protocol, regulatory, and ICH-GCP compliance
• Apply risk-based monitoring approaches including root cause analysis and corrective/preventive actions
• Ensure data accuracy through source data review, source data verification, and CRF review
• Assess investigational products through inventory checks and documentation review
• Prepare monitoring reports, follow-up letters, and documentation in a timely manner
• Escalate site issues and protocol deviations to clinical management and ensure resolution
• Maintain regular communication with investigative sites between monitoring visits
• Support site initiation, routine monitoring, and trial close-out activities
• Ensure essential documents are complete and audit-ready as per regulatory requirements
• Update study systems including CTMS and provide trial progress reports to Clinical Team Manager
• Facilitate effective communication between sites, sponsors, and project teams
• Support audits, inspections, and regulatory requests
• Maintain administrative activities including timesheets and expense reports
• Contribute to project deliverables, process improvements, and team initiatives

Qualification
• Bachelor’s degree in Life Sciences or related field OR Registered Nursing qualification
• Formal academic or vocational qualification relevant to clinical research

Experience
• Minimum 2+ years of experience as a Clinical Research Associate or onsite clinical monitor
• Experience across different monitoring models including FSO, FSP, or government studies preferred
• Willingness to travel as required for monitoring activities

Skills
• Strong clinical monitoring and site management skills
• Working knowledge of ICH-GCP, regulatory requirements, and SOPs
• Risk-based monitoring, root cause analysis, and problem-solving ability
• Strong written and verbal communication skills
• Excellent organisational and time management skills
• High attention to detail and data quality focus
• Ability to work independently and within cross-functional teams
• Proficiency in Microsoft Office and clinical trial systems
• Adaptability and flexibility in dynamic clinical research environments

About the Company
Thermo Fisher Scientific is a global leader in scientific services, supporting life-changing research through its PPD® clinical research portfolio. Operating across more than 100 countries, the organization delivers end-to-end clinical development services, helping sponsors bring innovative therapies to market while advancing global health outcomes through high-quality, compliant, and efficient clinical research.