Senior Clinical Research Associate (Remote)

Job summary

This role involves managing clinical trial sites for a dedicated sponsor while ensuring compliance with relevant regulations and standards.

Qualifications

• Degree in life sciences or a related field, or equivalent experience
• Minimum 2 years of clinical monitoring experience
• Preferably 1+ year experience in oncology studies
• Strong knowledge of ICH GCP and clinical trial processes
• Ability to work independently with minimal supervision
• Experience with SAE reporting and clinical data review
• Strong organizational, problem-solving, and communication skills

Responsibilities

Additional Responsibilities

Additional Information

• Manage clinical trial sites according to SOPs, ICH GCP, and sponsor requirements
• Conduct all types of monitoring visits including PSV, SIV, routine, and close-out
• Ensure patient safety by verifying informed consent and adherence to protocols
• Maintain data integrity through source data verification, query management, and data review
• Keep site regulatory documentation and electronic Trial Master File (eTMF) updated
• Oversee investigational product handling, storage, and accountability
• Ensure audit readiness and compliance with quality standards and CRA metrics
• Prepare monitoring plans, visit reports, and study documentation
• Train site staff and ensure they are equipped to run the study
• Review source data for accuracy and completeness, and resolve discrepancies
• Track study progress, investigational product shipments, and serious adverse events
• Collaborate with study teams to meet timelines and deliverables
• Support investigator and site management activities
• Work with Clinical Trial Management Systems (CTMS) and other eClinical systems
• Attend investigator meetings and project calls
• Provide site training and support onboarding of new team members
• Contribute to study planning and monitoring strategy
• Willingness to travel approximately 60% to study sites.