Clinical Research Associate II

• Support delivery of clinical studies at allocated sites as an active participant in local study teams
• Serve as the main contact with study sites and monitor study conduct
• Prepare, initiate, monitor and close assigned clinical study sites
• Contribute to investigator selection and, where required, study start-up and regulatory maintenance
• Train, support and advise investigators and site staff on study-related matters and RbQM principles
• Confirm required site-staff training and inspection readiness
• Participate in local study team and national investigator meetings
• Drive site performance, resolve study-related issues and escalate as appropriate
• Update CTMS and other systems with site data
• Manage study, drug supplies and drug accountability
• Perform remote and onsite monitoring visits, remote data checks, SDR, CRF review and SDV
• Conduct site quality risk assessments and adapt monitoring intensity
• Ensure timely data-query resolution and accurate Serious Adverse Event reporting
• Prepare monitoring visit reports and provide feedback to Principal Investigators
• Follow up on outstanding site actions
• Escalate quality, privacy and compliance issues
• Assist with inspection readiness, audits and regulatory inspections
• Collect and upload essential documents to the eTMF and support quality-control checks
• Ensure study documents are ready for archiving and eTMF completion
• Provide research-related market feedback and collaborate with local MSLs
• Ensure compliance with company policies, ethics requirements and applicable regulations

• 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 a scientific discipline or health care
• Equivalent combination of education, training and experience may be accepted in lieu of degree

• Fully remote work arrangement