Senior Clinical Research Associate, Level II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation
• Manage sponsor procedures and guidelines across different monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects’ rights and well-being and ensure data reliability
• Ensure audit readiness and build collaborative relationships with investigational sites
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and CRF review
• Assess investigational product inventory and records
• Prepare timely reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring according to approved monitoring plans
• Participate in investigator payment processes and investigator meetings
• Help identify qualified investigators and initiate clinical trial sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Track trial status and provide progress updates
• Maintain complete and accurate study systems, including clinical trial management systems
• Facilitate communication among sites, clients, and internal project teams
• Respond to client, company, and regulatory audits and inspections
• Complete expense reports and timesheets
• Support project publications, tools, process improvements, and other project initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Minimum 2 years of clinical monitoring experience, or comparable experience in clinical trials, medical terminology, medical research, clinical research, healthcare, or a health sciences field with formal training in medical terminology and anatomy
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Basic medical/therapeutic area knowledge and medical terminology
• Working knowledge of ICH GCPs, applicable regulations, and procedural documents
• Good oral and written communication skills
• Good interpersonal, organizational, and time management skills
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Flexibility and adaptability
• Critical thinking, root cause analysis, and problem-solving skills
• Ability to manage risk-based monitoring concepts and processes
• Ability to work independently or as part of a team
• Solid knowledge of Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Ability to travel frequently, generally 60–80%, including potential extended overnight stays

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunity to work with a global team
• Potential professional exposure across clinical trials, sponsors, and monitoring environments