Senior CRA – FSP

• 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 data review, source data verification, and CRF review during on-site and remote monitoring
• Assess investigational product inventory and records
• 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 payment processes
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update clinical study systems, including CTMS, and perform report quality-control checks
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and ensure protocol, regulatory, and ICH-GCP compliance
• Ensure trial closeout and retrieval of trial materials
• Maintain essential documents and conduct on-site file reviews
• Contribute to project publications, tools, process improvements, and additional study tasks
• Facilitate communication among investigative sites, the client company, and the project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete administrative tasks such as expense reports and timesheets

• 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
• 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
• 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 possible disclosure of vaccination status or other personal information

• Frequent travel generally 60–80%, including potential extended overnight stays
• Work performed in an office, laboratory, clinical, and/or home office environment
• Personal protective equipment provided/required, including protective eyewear, garments, and gloves