Clinical Research Director

2 weeks ago


Reston, Virginia, United States Genabio Diagnostics Full time

Key Responsibilities

  • Identify and qualify clinical sites, negotiate budgets and contracts to ensure successful study execution.
  • Develop and lead the creation of clinical study protocols and reports, ensuring compliance with regulatory requirements.
  • Collaborate with regulatory teams to prepare and submit FDA packages, ensuring timely and accurate submissions.
  • Oversee clinical sites, central labs, and third-party vendors to resolve issues efficiently and effectively.
  • Ensure clinical studies are completed on time and within budget, meeting project objectives.

Required Qualifications

  • Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
  • Minimum 10 years of clinical research experience, with a focus on medical devices and IVD products.
  • At least 5 years of experience with rapid self-test IVD products, with a strong understanding of FDA regulations.
  • Proven ability to communicate effectively with regulatory agencies.


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