Senior Clinical Research Associate, Level II

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor procedures, guidelines, monitoring environments, and required documentation
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Monitor investigator sites using a risk-based monitoring approach, including root cause analysis and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and case report form review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigative sites between monitoring visits and follow issues through resolution
• Participate in investigator meetings and help identify qualified investigators and sites
• Initiate sites, perform trial closeout, and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Track trial status, provide progress updates, and maintain study systems such as Clinical Trial Management Systems
• Facilitate communication among investigative sites, client companies, and internal project teams
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports, timesheets, and other administrative tasks
• Contribute to 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
• At least 2 years of clinical monitoring experience in a clinical environment, including clinical trials, medical terminology, medical research, clinical research, or health care; alternatively, health sciences experience with formal training in medical terminology and anatomy may be considered
• 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 with medical personnel
• Good interpersonal, organizational, and time management skills
• Critical thinking, root cause analysis, problem-solving, 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 possible overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

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