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About the Role:
We are seeking a Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for completing onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
Key Responsibilities:
- Verifying the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations
- Ensuring the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs
- Writing and submitting reports of investigational site findings and updates applicable tracking systems
- Escalating observed deficiencies, issues, and corrective and preventative action plans as appropriate
- Participating in audit preparation and follow-up activities as needed
Requirements:
- Bachelor's degree in a health, life sciences, or other relevant field of study
- Previous experience supporting clinical trials including 1 year of on-site monitoring experience
- Previous experience in oncology is a plus
- Travel is required
- All employees must read, write, and speak fluent English and host country language