Clinical Research Associate II
hace 2 meses
About the Role:
We are seeking a highly skilled Clinical Research Associate II to join our team at ESP Labcorp Development S.A.U. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials.
Key Responsibilities:
- Manage site activities in accordance with ICH GCP Guidelines and Fortrea's Standard Operating Procedures.
- Conduct site monitoring visits to ensure compliance with study protocols and regulatory requirements.
- Prepare and implement project plans to ensure timely completion of clinical trials.
- Verify informed consent procedures and protocol requirements to ensure subject protection.
- Review and verify source documents to ensure data integrity.
- Ensure site regulatory documents and eTMF/Sponsor Documents are complete and current.
- Manage study Investigational Product inventory and accountability.
- Ensure adherence to global quality control and CRA performance metrics.
- Ensure audit readiness at site level.
Requirements:
- University or college degree, or certification in a related allied health profession.
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Thorough knowledge of monitoring procedures.
- Basic understanding of the clinical trial process.
- Fluent in local office language and English, both written and verbal.
Experience:
- Minimum of 2 years of Clinical Monitoring experience.
About ESP Labcorp Development S.A.U.:
We are a leading provider of clinical research services, dedicated to revolutionizing the development process and delivering life-changing ideas and therapies to patients in need. Our collaborative workspace fosters personal growth and enables our team members to make a meaningful global impact.
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