Senior Clinical Research Associate

Summary

Join Karius, a life science startup, as a Clinical Trial Associate to ensure data accuracy and traceability in clinical studies. Support the Clinical Trial Manager in various activities, including site management and clinical study materials development. Conduct site monitoring visits, perform source data verification, and track regulatory document submissions. Maintain essential regulatory documents, provide GCP training, and oversee investigational product management. Develop patient recruitment strategies, document monitoring activities, and resolve site-level issues. Collaborate with cross-functional teams and participate in audits and inspections. Assist with vendor management and contribute to process improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related field is required
• Minimum of 4-6 years of experience in clinical research, including IVD experience
• On-site or remote site monitoring experience and ability to monitor multiple sites and complex studies
• Solid understanding of clinical trial processes, ICH-GCP, and regulatory requirements (FDA, EMA)
• Proficiency with EDC systems, CTMS, eTMF
• Excellent communication, problem-solving, and organizational skills
• Ability to work independently and collaboratively in a fast-paced, dynamic environment
• Strong attention to detail and commitment to delivering high-quality work

Responsibilities

• Support the Clinical Trial Manager in site identification, qualification, initiation, routine monitoring, and close-out activities
• Conduct site monitoring visits (remote and onsite) to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines
• Perform Source Data Verification (SDV) and ensure timely and accurate completion of case report forms (CRFs) in the electronic data capture (EDC) system
• Track and follow up on regulatory document submissions, Institutional Review Board (IRB) approvals, recruitment progress, and data collection timelines
• Ensure timely collection, maintenance, and filing of essential regulatory documents in the Investigator Site File (ISF) and Trial Master File (TMF), ensuring audit-readiness at all times
• Provide protocol-specific and GCP training to investigators, study coordinators, and site staff, ensuring a thorough understanding of study procedures and compliance expectations
• Oversee investigational product (IP) tracking, temperature-controlled storage, inventory management, and accountability at each clinical site
• Develop, support, and implement site-specific patient recruitment and retention strategies; monitor site enrollment performance and escalate concerns to the CTM
• Document all monitoring activities, observations, protocol deviations, and site correspondence through detailed visit reports, follow-up letters, and issue escalation when necessary
• Assist in the identification and resolution of site-level issues; contribute to the development and execution of corrective and preventive action (CAPA) plans
• Ensure site adherence to company Standard Operating Procedures (SOPs), study protocols, FDA regulations, and international ICH-GCP standards
• Participate in internal team meetings, site teleconferences, and investigator meetings as needed to support trial execution
• Collaborate with cross-functional teams to ensure trial objectives and timelines are met
• Support inspection readiness and participate in audits and regulatory inspections as needed
• Assist with vendor management and oversight (e.g., central labs, imaging providers, logistics services)
• Participate in the review and development of study documents, including protocols, informed consent forms, monitoring plans, and case report forms
• Perform additional tasks and special projects as required to support clinical trial operations and continuous process improvement initiatives