Clinical Research Associate

4 weeks ago


Dallas, Texas, United States Cedent Consulting Inc Full time

Clinical Research Associate Role

Cedent Consulting Inc is seeking a skilled Clinical Research Associate to join our team in the medical devices industry. As a Clinical Research Associate, you will be responsible for monitoring clinical trials, ensuring compliance with regulatory requirements, and supporting the development of medical devices from inception to market.

Key Responsibilities:

  • Site Management:
    • Conduct site selection, initiation, monitoring, and closure activities.
    • Establish and maintain strong relationships with clinical sites and investigators.
  • Monitoring Activities:
    • Perform regular site visits to ensure adherence to study protocols and regulatory guidelines.
    • Review source documents and ensure accuracy of data entry into clinical databases.
  • Regulatory Compliance:
    • Ensure compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB) regulations, and other relevant standards.
    • Prepare for and participate in regulatory inspections and audits.
  • Documentation:
    • Maintain essential documents and study files in accordance with company policies and regulatory requirements.
    • Assist in the preparation and submission of study-related documents to regulatory agencies.
  • Collaboration:
    • Work closely with cross-functional teams, including clinical operations, data management, and biostatistics, to facilitate timely study progress.
    • Provide training and support to site personnel regarding protocol and procedures.
  • Reporting:
    • Prepare and present monitoring reports addressing any issues and recommending corrective actions as needed.
    • Track and manage study timelines and milestones.

Requirements:

  • Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
  • Minimum of 2 years of experience as a CRA, specifically within the medical device industry.
  • Strong understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Proficient in Microsoft Office Suite and clinical trial management software.


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