Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate monitoring clinical trials for Thermo Fisher Scientific. Ensuring site compliance, data integrity, regulatory adherence, and audit readiness across clinical studies.
Responsibilities:
- 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, documentation, and monitoring environments
- Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs
- Ensure subjects' rights, well-being, data reliability, and audit readiness
- Develop 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 failures and corrective/preventive actions
- Ensure data accuracy through source document review, source data verification, and CRF review
- Assess investigational product inventory and records
- Prepare monitoring reports and letters; escalate and follow deficiencies through resolution
- Maintain contact with investigative sites between monitoring visits
- Conduct monitoring tasks according to approved monitoring plans
- Participate in investigator payment processes and findings resolution
- Track trial status and provide 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 qualified investigators and sites
- Initiate clinical trial sites and make compliance recommendations
- Close out trials and retrieve trial materials
- Ensure essential documents are complete and conduct on-site file reviews
- Assist with project publications, tools, team calls, trip report reviews, and newsletters
- Facilitate communication among investigative sites, client companies, and the project team
- Respond to company, client, and regulatory requirements, audits, and inspections
- Complete expense reports and timesheets
- Contribute to process-improvement initiatives
Requirements:
- 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
- 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
- Risk-Based Monitoring concepts and processes
- Strong critical thinking, root cause analysis, and problem-solving skills
- 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 vaccination-status or personal-information disclosure
- Ability to travel frequently, generally 60–80%, including possible extended overnight stays
- Ability to use required personal protective equipment
Benefits:
- Fully remote work arrangement
- Standard office hours (40 hours per week)
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