Clinical Research Associate Specialist
7 days ago
**Job Overview**
We are seeking a highly motivated Clinical Research Associate to join our Regulatory and Clinical Affairs organization at Della Infotech. As a key member of our team, you will play a critical role in ensuring the quality of FDA submissions and securing necessary approvals for our products.
The successful candidate will have a strong background in clinical research, with a minimum of 2 years of experience in supporting the management of in-house and/or external clinical studies. A bachelor's degree in a related science is required, and certification as a Clinical Research Professional (CCRP) is a plus.
**Responsibilities:**
- Coordinating and conducting activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics
- Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements
- Collecting all clinical study essential documents
- Ensuring that CRO activities and timelines are in coordination with project requirements
- Implementing and documenting communication with CRO and laboratories to ensure project progress
- Real-time escalation of clinical studies issues to Clinical Study Managers
- Ensuring compliance with company SOPs
- Assisting in performing remote lab assessment visits
**Estimated Salary:** $80,000 - $110,000 per annum, depending on qualifications and experience.
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