Clinical Research Coordinator III

2 days ago


Humble, Texas, United States DM Clinical Research Full time
Job Summary

We are seeking a highly skilled Clinical Research Coordinator III to join our team at DM Clinical Research. The successful candidate will be responsible for ensuring the quality of research conducted at assigned investigative sites, in accordance with sponsor protocol, FDA Regulations, and ICH/GCP guidelines.

Key Responsibilities
  • Completing all required training, including ICH-GCP Certification and IATA Certification, in a timely manner.
  • Conducting and overseeing study subject visits, and documenting these in a timely manner.
  • Adhering to ALCOA-C Standards with all clinical trial documentation.
  • Completing and overseeing data entry and query resolution in a timely manner.
  • Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants, and Sponsor/CRO representatives.
  • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, organizational SOPs, guidance documents, and assigned study protocol(s).
  • Supervising visit preparedness for all sponsor and CRO visits.
  • Overseeing reporting of Adverse and Serious Adverse Events and Safety Information to the appropriate authorities.
  • Striving to meet Sponsor subject enrollment goals.
Requirements
  • High School Diploma or equivalent required.
  • Bachelor's degree preferred.
  • Minimum of 5 years experience in Clinical Research.
  • Supervisory experience preferred.
  • Wide therapeutic range of clinical trials experience preferred.
  • Regulatory research experience is a plus.


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