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/monitoring procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Protect subject rights, well-being, and data reliability
• Maintain audit readiness and collaborative relationships with investigational sites
• Monitor investigator sites using a risk-based monitoring approach
• Perform root cause analysis, identify site process failures, and implement corrective/preventive actions
• Ensure data accuracy through SDR, SDV, 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 approved monitoring plans
• Participate in investigator payment processes
• Track trial status and provide progress reports to the Clinical Team Manager
• Update study systems, including CTMS, and perform quality-control checks of CTMS reports
• Participate in investigator meetings and identify qualified investigative sites
• Initiate clinical trial sites and make compliance recommendations
• Conduct trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters, and lead CRA team calls
• Facilitate communication among investigative sites, the client company, and the project team
• Respond to company, client, and regulatory audits and inspections
• Complete expense reports, timesheets, and other administrative tasks
• 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
• Valid driver's license where applicable
• Solid experience in oncology clinical trials
• Experience in rare diseases and neurology recommended
• Effective clinical monitoring skills
• Understanding 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
• Effective interpersonal, organizational, and time management skills
• Strong attention to detail
• Ability to work in a team or independently
• 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
• 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 and use required personal protective equipment

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