CRA / Sr CRA

• Conduct on-site and remote monitoring visits using a risk-based monitoring approach
• Review source documentation, case report forms (CRFs), and study data for accuracy, completeness, and compliance
• Perform site management activities, including site initiation, routine monitoring, and close-out visits
• Assess investigational product accountability through inventory and records review
• Identify site process issues, perform root cause analysis, and support corrective and preventive actions
• Maintain essential documents according to ICH-GCP and regulatory requirements
• Prepare monitoring reports, follow-up letters, and study documentation within established timelines
• Communicate with investigational sites, sponsors, and internal study teams
• Support site identification, feasibility, and investigator engagement activities
• Track study progress and maintain records in clinical trial management systems and other study tools
• Support regulatory inspections, audits, and quality initiatives
• Contribute to process improvements, project deliverables, and knowledge sharing across teams
• Safeguard subject safety, data integrity, audit readiness, and overall study quality

• Bachelor’s degree in Life Sciences, Nursing, or a related healthcare field, or an equivalent combination of education and experience
• Valid driver’s license, where applicable
• Ability to travel as required
• Relevant clinical research and/or clinical monitoring experience in a pharmaceutical, biotechnology, CRO, or healthcare environment
• Knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulations
• Understanding of medical terminology and therapeutic areas
• Strong critical thinking, problem-solving, and root cause analysis skills
• Experience with Risk-Based Monitoring (RBM) methodologies
• Excellent organizational and time management skills
• Strong written and verbal communication skills, including professional interaction with investigators and site personnel
• Ability to work independently and collaboratively in a global team environment
• Proficiency with Microsoft Office and clinical trial systems
• Strong attention to detail and commitment to quality
• English proficiency required
• Frequent travel, generally 60–80%, with possible extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves
• Potential exposure to biological fluids, infectious organisms, electrical office equipment, and fluctuating or extreme temperatures

• Fully remote work mode
• Full-time employment
• Standard Monday–Friday schedule