Clinical Research Associate Specialist

7 days ago


Carlsbad, United States Della Infotech Full time

**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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