Clinical Research Associate
Há 6 dias
We are seeking a highly skilled Clinical Research Associate I to join our team at ICON. As a Clinical Research Associate I, you will play a critical role in the success of our clinical trials by ensuring the integrity of clinical data and compliance with approved protocols, GCP, and applicable regulations.
Key Responsibilities- Conduct onsite and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
- Qualify potential investigative sites, initiate clinical trials, maintain study files, provide instructions to site personnel, and perform study close-out activities.
- Verify the protection of study participants by confirming informed consent procedures and protocol adherence to applicable regulations.
- Ensure the integrity of clinical data and compliance with approved protocols, GCP, and applicable regulations.
- Manage investigative site staff to facilitate trial deliverables, such as subject enrollment and data deliverables.
- Verify proper management and accountability of Investigational Product (IP).
- Write and submit reports of investigational site findings and updates to applicable tracking systems.
- Evaluate and escalate observed deficiencies, issues, and corrective and preventative action plans as necessary.
- Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study.
- Assist with resolution of investigational site/data queries.
- Perform key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
- Participate in audit preparation and follow-up activities as needed.
- Undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution.
- Healthcare professional licensure, such as a registered nurse.
- Previous experience supporting clinical trials, including solid onsite monitoring experience.
- Fluency in English and host country language.
At ICON, we value diversity, inclusion, and belonging. We offer a competitive salary, a range of benefits, and opportunities for professional growth and development. We are committed to providing an inclusive and accessible environment for all candidates and employees.
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