Clinical Research Associate

Position: Clinical Research Associate

Responsibilities:

• Serve as the primary contact for assigned clinical sites, facilitating communication and resolving issues.
• Manage patient enrollment, data entry, data monitoring, and safety reporting.
• Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), Site Monitoring Visits (SMV), and Site Closeout Visits (SCV)
• Ensure Good Clinical Practice (GCP) compliance and accurate data verification.
• Perform routine monitoring visits, manage data queries, and ensure the integrity of trial data.
• Oversee the execution of monitoring plans, preparing reports, and resolving site issues.
• Provide site training and support, including logistics for leukapheresis and CAR-T shipments.
• Facilitate technology support and ensure sites have access to necessary materials and information.
• Prepare and complete monitoring reports and ensure timely submission of regulatory documents.
• Manage Clinical and Investigational Medicinal Product (IMP) supplies, ensuring proper storage and accountability.
• Execute monitoring plans according to study timelines, adjusting strategies based on enrollment needs.
• Participate in site selection, start-up activities, and ensure readiness for audits.
• Up to 35% of traveling to clinical trial sites will be required.

Qualifications:

• Bachelor’s degree in a scientific or healthcare field.
• Previous experience as a Clinical Research Associate.
• Oncology and/or gene therapy site monitoring experience is beneficial.
• Familiarity with regulatory compliance and GCP guidelines.
• Proficiency in English, both written and verbal.

Preferred Qualifications:

• Ability to build and maintain professional relationships with site personnel and team members
• Skilled in analyzing data, identifying issues, and implementing solutions.
• Effective communication abilities to convey complex information clearly and liaise between site staff and the research team.
• Attention to detail, flexibility in managing multiple priorities and adapting to changing project needs.
• Comfortable using clinical trial management systems and addressing basic technology issues, with the ability to escalate more complex problems appropriately.
• Open to traveling to clinical sites as required for monitoring and training purposes.