Senior CRA - FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote or on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor/monitoring-environment procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Maintain audit readiness and 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 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
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update clinical study systems, including CTMS, and perform required quality-control checks
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and make recommendations regarding site acceptability
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and properly maintained
• Conduct on-site file reviews
• Assist with project publications, tools and other study tasks
• Facilitate communication among investigative sites, client companies and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports, timesheets and other administrative tasks
• Contribute to 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, or comparable experience
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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
• Flexibility and adaptability
• 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 potential disclosure of vaccination status or other personal information
• Ability to work in office, laboratory, clinical and/or home-office environments
• Ability to travel frequently, generally 60–80%, including drives to site locations and possible overnight stays
• Ability to use required personal protective equipment and work around biological fluids and potentially infectious organisms

• Fully remote work mode
• Standard Monday–Friday work schedule
• Frequent travel and potential extended overnight stays as required by the role