Senior Clinical Research Associate - FSP

• Perform and coordinate clinical monitoring and site management activities
• 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
• Ensure subject rights, well-being, data reliability, and audit readiness
• 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 through inventory and records review
• Document observations in reports and letters; escalate deficiencies and follow issues through resolution
• Maintain contact with investigative sites between monitoring visits and verify protocol compliance and timely data recording
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems, including the Clinical Trial Management System, and perform required report quality-control checks
• Participate in investigator meetings and identify potential investigators with the client company
• Initiate clinical-trial sites and make recommendations regarding site acceptability and compliance
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Assist with project publications and tools and contribute ideas to the project team
• Perform additional study tasks assigned by the Clinical Team Manager, such as trip-report review, newsletter creation, and leading CRA team calls
• 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 initiatives and process improvement

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• Minimum of 3 years of completed on-site clinical monitoring experience
• Minimum of 2 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials
• Effective clinical monitoring skills
• Understanding and application of medical/therapeutic area knowledge and medical terminology
• Understanding and 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, including communication with medical personnel
• Customer focus, listening skills, attention to detail, and ability to perceive underlying customer 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 sponsor/client/site requirements, including vaccination-status or other personal-information disclosures when required
• Ability to travel frequently, generally 60–80%, including frequent drives to site locations and 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

• Fully remote work arrangement
• Standard Monday–Friday work schedule