Senior Clinical Research Associate

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor procedures, guidelines, and monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Monitor investigator sites using risk-based monitoring, including root cause analysis 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 deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Track trial status and provide progress reports to the Clinical Team Manager
• Update clinical study systems and perform required quality-control checks
• Participate in investigator meetings and identify qualified investigators and sites
• Initiate clinical trial sites and ensure trial closeout and retrieval of materials
• Ensure essential documents are complete and conduct on-site file reviews
• Support 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, 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
• On-site monitoring experience in Rare Diseases and Alzheimer's clinical trials
• Valid driver's license where applicable
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• 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
• Effective interpersonal, organizational, and time management skills
• Strong attention to detail
• Ability to work independently and 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 where required
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to use required personal protective equipment and work around biological fluids and infectious organisms

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Frequent travel expenses likely covered as part of business travel (not explicitly stated)