Senior Clinical Research Associate

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required documentation and sponsor/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
• Ensure audit readiness and 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 SDR, SDV, and CRF review during on-site and remote monitoring
• Assess investigational product through physical inventory and records review
• Document observations in reports and letters and escalate deficiencies to clinical management
• Maintain contact with investigational sites between visits to confirm protocol compliance, issue resolution, and timely data recording
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payment processes and issue/finding resolution
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems, including CTMS, and perform CTMS report quality-control checks when required
• Participate in investigator meetings and help identify and initiate qualified investigative sites
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications/tools and other study tasks assigned by the CTM
• Facilitate communication among investigative sites, the client company, and the PPD project team
• Respond to company, client, and regulatory requirements, 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
• Experience required in Oncology and Cell therapy
• Valid driver's license where applicable
• 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 with medical personnel
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Effective interpersonal skills
• Strong attention to detail
• 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 disclosure of vaccination status or other personal information where required
• Ability to work in office, laboratory, clinical, and/or home-office environments
• Ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible extended overnight stays
• Ability to work with potential exposure to biological fluids and infectious organisms
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves
• Ability to tolerate fluctuating or extreme temperatures on rare occasions

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