Clinical Research Associate responsible for monitoring oncological studies at AstraZeneca. Ensuring timely and complete submission of study data and documentation in a complex research environment.
About the role
- Senior Clinical Research Associate responsible for site management and monitoring for Karius. Ensures compliance with protocols and GCP guidelines during clinical trials.
Responsibilities
- Perform on-site and remote monitoring visits for assigned sites in accordance with the Clinical Monitoring Plan, ICH GCP guidelines, and applicable local regulations.
- Conduct source data verification to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documents and the protocol.
- Manage day-to-day communication with assigned sites, supporting enrollment, query resolution, and overall site performance.
- Proactively identify and document site level risks and issues, respond to study specific questions, and manage escalations through to resolution.
- Oversee the collection, review, and maintenance of essential regulatory and study documents to ensure inspection readiness.
- Collaborate closely with investigators and internal clinical teams to support effective study start up, conduct, and close out and to ensure successful trial execution.
- Oversee the execution of clinical trial activities in accordance with Good Clinical Practices.
Requirements
- Bachelor's degree in a life sciences or health-related field.
- 5+ years of clinical trial experience to include study monitoring; experience with LDTs or in vitro diagnostic devices strongly preferred. 3+ years experience with a master's degree.
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.
- Ability to travel frequently, sometimes on short notice, and manage travel logistics effectively.
- Proficiency in Microsoft Office and clinical trial management systems (CTMS) preferred.
- CCRA/CCRP certification is desired.
Benefits
- Travel required (up to 80%)
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