Clinical Research Coordinator Lead

1 week ago


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

We are seeking a highly skilled Clinical Research Coordinator Lead to join our team at HARACEC COMPLETE HEALTHCARE PLLC. The successful candidate will be responsible for managing multiple clinical trials, ensuring compliance with regulatory requirements, and maintaining effective communication with study sponsors and IRBs.

Key Responsibilities
  • Conduct daily execution of protocol, including obtaining informed consent and executing study procedures.
  • Maintain proper source data documentation on CRFs, ensuring GCP guidelines, and performing data entry and query resolution.
  • Monitor subject safety and ensure subject compliance with the study protocol.
  • Prepare IRB applications, protocol, and informed consent approval to conduct the study, and maintain communication with the IRB regarding AE/SAEs renewals and protocol amendments.
  • Assist in the creation of SOPs for each study and ensure compliance with regulatory, ICH guidelines requirements.
  • Work closely with study monitors to maintain double-blind protocol, 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 properly 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, ensuring safety monitoring or symptomatic treatment is initiated as prescribed or as specified in the protocol.

Working Hours: Monday through Friday, 8AM to 5PM



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