Senior CRA Level I

• Perform and coordinate all aspects of clinical monitoring and site management
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor or monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subjects' rights and well-being and ensure data reliability and audit readiness
• 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
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes and findings follow-up
• Track trial status, provide progress updates to the Clinical Lead, and update study systems such as CTMS
• Perform CTMS report quality-control checks where required
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites in collaboration with the client
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, team calls, and other study tasks
• Facilitate communication among investigative sites, the client company, and the project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to project work and process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• 2+ years of experience as a clinical research monitor
• Equivalent combination of appropriate education, training, and/or directly related experience may be considered
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Understanding and demonstrated application of ICH GCPs, applicable regulations, and procedural documents
• Critical thinking, root cause analysis, and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Effective oral and written communication skills with medical personnel
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Effective interpersonal skills
• Organizational and time management skills
• Flexibility and adaptability
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to comply with sponsor, client, and site requirements, including possible disclosure of vaccination status or other personal information
• Ability to travel frequently, generally 60–80%, including extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to use required personal protective equipment and work around biological fluids and potentially infectious organisms

• Fully remote work mode
• Standard Monday–Friday work schedule
• Exposure to professional development through collaboration on project publications, tools, process improvement initiatives, and varied study tasks