Sr. Clinical Research Associate
Company: Karius
Location: Redwood City, CA (Hybrid) or Remote (USA)
Employment Type: Temporary Agency Worker
Company Overview:
Karius is a venture-backed life science startup transforming how pathogens and microbes are detected in the human body. By leveraging microbial cell-free DNA and cutting-edge genomics, Karius offers breakthrough diagnostic capabilities that help clinicians and researchers solve complex infectious disease cases, accelerate biomarker discovery, and improve patient outcomes globally.
Role Summary:
The Sr. Clinical Research Associate will support clinical trial execution by ensuring accurate data collection, compliance with regulatory requirements, and effective site management. This contract role is instrumental in managing monitoring activities, supporting trial operations, and contributing to study material development.
Reports To:
Director, Clinical Operations
Primary Responsibilities:
Assist with site identification, qualification, initiation, monitoring, and close-out activities.
Conduct on-site and remote monitoring visits, ensuring protocol and regulatory compliance.
Perform Source Data Verification (SDV) and manage data integrity in EDC systems.
Track IRB submissions, regulatory documents, recruitment progress, and timelines.
Maintain ISF and TMF for audit readiness; ensure regulatory document completeness.
Deliver protocol-specific and GCP training to site staff.
Manage investigational product (IP) tracking and storage at clinical sites.
Support and implement patient recruitment and retention strategies.
Document all monitoring activities, protocol deviations, and site communication.
Assist in site-level issue resolution and CAPA implementation.
Ensure compliance with FDA, ICH-GCP, and company SOPs.
Collaborate cross-functionally and support trial milestone achievement.
Participate in audits, inspections, and inspection readiness efforts.
Contribute to vendor oversight and study document development.
Support special projects to enhance trial execution and process improvement.
Position Requirements:
Bachelor’s degree in Life Sciences, Nursing, or a related field.
4–6 years of experience in clinical research, including IVD trial experience.
Strong knowledge of ICH-GCP and regulatory requirements (FDA, EMA).
Proficient in EDC, CTMS, and eTMF systems.
Experience monitoring multiple sites and complex clinical trials.
Excellent communication, organizational, and problem-solving skills.
Ability to work independently and collaboratively in a fast-paced environment.
Must be located near a major airport for travel needs.
Physical Requirements:
Extended periods of sitting/standing; moderate noise; standard office/lab/clinical work environment.
Equal Opportunity Statement:
Karius is an equal opportunity employer committed to building an inclusive and diverse team. All qualified applicants will be considered without regard to race, color, gender, age, disability, sexual orientation, religion, veteran status, or other protected classifications.
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