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Clinical Research Associate II
4 weeks ago
Key Responsibilities:
As a Clinical Research Associate II at ICON Strategic Solutions, you will be responsible for the management of clinical trials, including site selection, monitoring visits, and data management. You will work closely with the Clinical Site Manager to ensure the successful execution of trials.
Key Responsibilities include:
- Contribute to the identification of new sites for clinical trials and analyze their capability to support trial inclusion.
- Assume an ambassadorial role to facilitate communication between sites and Novartis CPO to increase the value proposition to investigators.
- Facilitate the preparation and collection of site and country-level documents during all phases of the trial and support the Clinical Site Manager in the oversight of Country and Site Trial Master Files (TMF).
- Negotiate investigator remuneration and prepare financial contracts between investigational sites and investigators.
- Implement complete site management, including monitoring visits, regulatory assessment, drug supply management, and ensure compliance with protocol, GCP, global and local regulations, and global and local processes.
- Identify problems at sites, resolve issues, and escalate as appropriate.
- Collaborate with the Clinical Site Manager to ensure recruitment and execute contingency plans as needed.
- Complete preparation and generation of visit monitoring reports as per relevant SOP and review and manage data at site to resolve technical and content issues on a continuous basis to achieve timely database lock targets.
- Implement site close-out activities and generate site close-out reports and provide feedback on site performance for future trial site feasibility/selection.
