Clinical Research Associate

1 day ago

Tustin, California, United States RemX Full time
Job Summary

The Clinical Research Coordinator / Project Manager plays a pivotal role in overseeing clinical trials and research studies to ensure compliance with regulatory standards and protocols. This position requires a strong understanding of clinical research methodologies, patient monitoring, and adherence to FDA regulations.

Key Responsibilities:

  • Develop and write publications/articles, modify/ add new graphs, numbers, charts and verbiage with new updates.
  • Work alongside cardiologists, neurologists, and orthopedic surgeons on publications.
  • Develop and implement clinical research protocols in alignment with regulatory requirements.
  • Ensure compliance with HIPAA regulations and maintain confidentiality of patient information.
  • Monitor patient vital signs and collect relevant data during clinical trials.
  • Utilize statistical software for data analysis and interpretation of research results.
  • Collaborate with cross-functional teams to streamline clinical development processes.
  • Train and supervise staff on clinical procedures, including phlebotomy techniques when necessary.
  • Maintain thorough documentation of all research activities, ensuring accuracy and completeness.
  • Stay informed about advancements in medical terminology and clinical research practices.
  • Conduct regular audits to ensure adherence to study protocols and FDA regulations.

Requirements:

  • Bachelor's degree in a relevant field (i.e. nursing, life science, public health)
  • 5+ years of relevant experience or combination of education, training, and relevant experience.
  • Clinical research writing is required.
  • Advanced degree preferred.
  • Strong knowledge of clinical research methodologies and practices.
  • Proficiency in using statistical software for data analysis.
  • Familiarity with medical terminology relevant to clinical trials.
  • Experience in patient monitoring techniques and vital signs assessment.

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