**Local candidates only**

The Clinical Research Associate (CRA) position reports into Clinical Affairs management to execute research and strategies to achieve the Company’s goals.  Major responsibilities include conducting clinical trial monitoring and site training and ensuring compliance with clinical protocols and Good Clinical Practice (GCP)..  Successful candidates are self-starters who can work independently and be able to meet timelines and goals in a fast paced and evolving environment. We are looking for qualified candidates based in the following areas: west coast, central, and east coast.  

RESPONSIBILITIES:

  • Conduct monitoring visits to ensure compliance with GCP and the study protocol including query generation and resolution
  • Conduct site qualification, initiation, close-out and audit visits as needed, including generating related reports
  • Assist in development and review of clinical protocols, case report forms (CRFs) and monitoring plans
  • Supervise collection of regulatory documents from clinical sites
  • Ensure site master files are accurate, complete and current
  • Support virtual and in-person meetings with investigators and research staff
  • Maintain positive working with relationships with investigators and research staff at clinical trial sites
  • Support tracking of study related timelines and budgets
  • Work collaboratively and effectively with investigators, research site staff, and Nalu teammates
  • Review study data and resolution of queries
  • Assist in writing and review of clinical study reports and related reports
  • Support patient recruitment and retention activities


REQUIREMENTS:

  • Bachelor’s degree in a scientific discipline, or equivalent experience within a scientific/medical field (medical technician, nursing, allied health, etc.)
  • Minimum of 3 years of experience working as a clinical research associate, preferably with a medical device company
  • Experience and ability to work in the operating room environment
  • Working knowledge of FDA regulations related to clinical studies and ISO 14155:2020
  • Working knowledge of medical and scientific terminology
  • Demonstrated patient communication and management skills
  • Demonstrated ability to handle multiple projects simultaneously and meet timelines in a dynamic workplace environment
  • Demonstrated problem-solving abilities in managing clinical sites and demonstrated tactfulness and diplomacy in dealing with investigators and study coordinators
  • Must be able to work independently
  • Ability to travel 25% or more

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