Lead Clinical Research Specialist

2 weeks ago

Van Nuys, California, United States Research & Development Institute, Inc. Full time
Position Overview

The Research & Development Institute, Inc. (RDI) is a pioneering tech-enabled Contract Research Organization (CRO) dedicated to assisting In Vitro Diagnostic manufacturers in navigating the complexities of FDA clearance by providing essential blood sample sourcing through partnerships with healthcare professionals and laboratories.

Following a significant investment in 2021, RDI has evolved from a founder-led initiative into a premier diagnostic CRO, equipped with scientific expertise and a CLIA-certified laboratory, enabling the management of larger and more lucrative projects.

We are currently seeking a Senior Clinical Research Associate to oversee the timely execution of our clinical trials, ensuring adherence to protocols while maintaining clear communication with our clients and clinical sites throughout the study lifecycle.

This role offers a long-term career trajectory with ample opportunities for advancement as RDI expands its operations nationwide. Additionally, RDI is committed to supporting the professional development of the selected candidate, including training and assistance in obtaining SOCRA CRA certification.

Key Responsibilities

  • Oversee diagnostic clinical studies, which are generally less complex than pharmaceutical trials.
  • Develop and manage study protocols, case report forms, budget negotiations, and regulatory documentation.
  • Assist clinical sites with Institutional Review Board (IRB) submissions and related documentation as necessary.
  • Maintain and update Diagnostica, our remote clinical trial management system.
  • Monitor clinical studies by creating monitoring plans, identifying and resolving queries, and ensuring compliance of site regulatory binders.
  • Foster and manage relationships with clinical sites, providing support during study initiation, addressing inquiries throughout the study, and ensuring timely payments and closeout processes.

Qualifications

  • A minimum of 2 years of experience in clinical research, either as a high-performing research coordinator or Clinical Research Associate (CRA).
  • Familiarity with Good Clinical Practice (GCP) guidelines and procedures.
  • Strong organizational, time management, budget management, and problem-solving abilities.
  • A proactive attitude, thriving in a dynamic, fast-paced small company environment.
Posted by ApplicantPro

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