Clinical Research Associate
About the role
The Clinical Research Associate (CRA) is responsible for monitoring and supporting clinical study sites to ensure the rights, safety, and well-being of study participants and the integrity of clinical data. The CRA conducts site qualification, initiation, interim monitoring, and closeout activities in accordance with study protocols, applicable regulations, Good Clinical Practice (GCP), and company standard operating procedures (SOPs). The CRA serves as a primary liaison between the sponsor and investigational sites, providing guidance on protocol requirements, regulatory compliance, data collection, and study conduct. Responsibilities include reviewing study documentation, verifying source data, identifying and resolving site issues, and ensuring timely and accurate reporting of study data and adverse events. The CRA maintains current knowledge of clinical research regulations, industry standards, and therapeutic area developments. The position may contribute to the development and review of study-related materials, including informed consent forms, case report forms, source documents, site training materials, and monitoring plans. The CRA collaborates with cross-functional teams to support study objectives, maintain data quality, and ensure successful execution of clinical research projects.
Responsibilities
- Conducts remote and on-site monitoring activities, including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, in compliance with standard operating procedures and applicable regulatory requirements.
- Develops monitoring expertise through ongoing training and collaboration with senior clinical team members.
- Reviews source documentation, verifies study data