Clinical Research Associate I

• Contribute to selection of potential investigators
• Support study start-up and regulatory maintenance, including site qualification visits and regulatory submissions where required
• Train, support and advise investigators and site staff on study-related matters, including RBQM principles
• Confirm required site staff training and maintain inspection readiness
• Participate in local study team and national investigator meetings
• Initiate, monitor and close study sites in compliance with procedures
• Share patient recruitment and site progress information with the local study team
• Drive site performance, identify and resolve study-related issues, and escalate as appropriate
• Update CTMS and other systems with study-site data
• Manage study, drug supplies and drug accountability
• Perform remote and on-site monitoring visits and remote data checks
• Perform Source Data Review, Case Report Form review and Source Data Verification
• Perform site quality risk assessments and adapt monitoring intensity
• Ensure timely data query resolution and accurate Serious Adverse Event reporting
• Prepare and finalize monitoring visit reports in CTMS and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate quality, privacy, CSP and ICH-GCP compliance issues
• Assist sites in maintaining inspection-ready Investigator Site Files
• Support audits and regulatory inspections
• Collect and upload essential documents into the eTMF and prepare documents for final archiving
• Provide local-market research information on sites, investigators and competing studies
• Ensure compliance with company policies, ethics codes and applicable legislation
• Collaborate with local MSLs as directed

• 0–2 years of prior relevant experience
• Good knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Written and verbal communication skills
• Good command of English language
• Degree in scientific discipline or health care, or equivalent combination of education, training and experience may be accepted in lieu of degree