Clinical Research Coordinator Lead

4 weeks ago


El Paso, Texas, United States HARACEC COMPLETE HEALTHCARE PLLC Full time
Job Summary

HARACEC COMPLETE HEALTHCARE PLLC seeks a highly skilled Clinical Research Coordinator Lead to manage multiple clinical trials from start-up to close-out. The ideal candidate will have excellent communication skills and the ability to maintain regulatory requirements.

Key Responsibilities:

  • Conduct daily execution of protocol, including obtaining informed consent and executing study procedures.
  • Maintain proper source data documentation on CRFs and ensure GCP guidelines are followed.
  • Monitor subject safety and ensure compliance with the study protocol.
  • Prepare IRB applications, protocol, and informed consent approval for study conduct.
  • Assist in creating SOPs for each study and ensure compliance with regulatory and ICH guidelines.
  • Work closely with study monitors to maintain double-blind protocol and administer IP, perform drug accountability, temperature monitoring, and storage requirements.
  • Maintain and create study-related supplies in stock, devices, and IP triggering with IRT to expedite shipment of IP when stock is needed.
  • Responsible for clinical tasks related to protocol and follow lab manual instructions when processing biological samples.
  • Recognize adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and site regulatory coordinator.

Requirements:

  • Excellent communication and organizational skills.
  • Ability to maintain regulatory requirements and ensure compliance with GCP guidelines.
  • Experience with clinical trials and study protocols.
  • Ability to work independently and as part of a team.


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