Performs data review of clinical trial data, including query management, and reconciliation review of external data against EDC data. May assist in creating study documents or running study reports and metrics. Files study documentation in electronic Trial Master File (eTMF) and department project files. Assists with quality review of activities performed by the CRO, as needed, and ensures compliance with own Learning Curricula, corporate and/or GXP requirements.
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The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Parexel is seeking Clinical Research Associates with at least 12 months recent oncology experience to be dedicated to a single sponsor. Manageable sites and protocols are the mantra, offering exciting challenges with time for your outside life. The role involves site management and monitoring activities across assigned oncology studies, working with industry leaders and world-class technology.
The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations. They ensure the sites deliver according to their respective commitment in the individual studies and act as a primary point of contact between site staff and the sponsor.
Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues. Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.