Senior CRA – Level I

• Perform and coordinate all aspects of clinical monitoring and site management
• Conduct remote or 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
• Ensure subject rights, well-being, data reliability, and audit readiness
• Develop 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 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; escalate and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes
• Provide trial-status tracking and progress updates to the Clinical Team Manager
• Update study systems, including CTMS, and perform required report quality-control checks
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and in place
• Conduct on-site file reviews
• Assist with project publications and tools and contribute ideas
• Perform additional study tasks assigned by the CTM, such as trip-report review, newsletter creation, and leading CRA team calls
• Facilitate communication between investigative sites, the client company, and the project team
• Respond to company, client, regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to process-improvement initiatives

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
• Minimum of 3 years of completed on-site clinical monitoring experience
• Minimum of 1.5 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology clinical trials
• 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 perceive underlying issues
• Effective interpersonal, organizational, and time management skills
• Flexibility and adaptability
• Ability to work independently or in 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 specific sponsor/client/site requirements, including possible vaccination-status or personal-information disclosures
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home-office environments and use required personal protective equipment

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunity to work with global pharmaceutical and biotechnology companies
• Frequent travel expenses may be covered (not explicitly stated)
• Personal protective equipment provided/required as applicable