Clinical Research Associate I

• 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 ensure audit readiness
• Monitor investigator sites using a risk-based monitoring approach
• Perform root cause analysis and develop corrective/preventive actions
• Ensure data accuracy through SDR, SDV and CRF review
• Assess investigational product through inventory and records review
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to the approved monitoring plan
• Participate in investigator payments and investigator meetings
• Identify and initiate qualified investigative sites
• Perform trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update study systems, including Clinical Trial Management Systems
• 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 and timesheets
• Assist with project publications/tools and contribute to process improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification
• Valid driver's license where applicable
• Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Proven clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Working knowledge 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
• Good oral and written communication skills
• Organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Flexibility and adaptability
• Ability to work in a team or independently
• Frequent travel 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

• Comprehensive health and wellbeing benefits
• Wellness programs
• Employee Assistance Program
• Flexible work arrangements
• Generous leave policies
• Option to purchase additional leave
• Paid birthday leave
• Company-paid parental leave
• Paid volunteer time
• Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning
• Workshops and mentorship programs
• Employer of Choice for Gender Equality