Clinical Research Coordinator Ii

Care Access

Remote, United States
Remote
Good clinical practices (gcp) adherence
Fda and ich gcp guideline knowledge
Informed consent process execution
The role involves utilizing Good Clinical Practices to screen, enroll, and monitor clinical research subjects while ensuring strict protocol and regulatory compliance

Job Summary

  • The role involves utilizing Good Clinical Practices to screen, enroll, and monitor clinical research subjects while ensuring strict protocol and regulatory compliance.
  • Candidates will manage study planning, scheduling conflicts, and maintain accurate data registration in both paper and electronic systems.
  • The position requires close collaboration with Principal Investigators, nurses, and sponsors to ensure safety reporting and document quality control.

Matching Summary

The role involves utilizing Good Clinical Practices to screen, enroll, and monitor clinical research subjects while ensuring strict protocol and regulatory compliance.

Skills & Requirements

Must-have

  • Good Clinical Practices (GCP) adherence
  • FDA and ICH GCP guideline knowledge
  • Informed consent process execution
  • Adverse event reporting procedures
  • Investigator Site File management
  • Electronic data entry and verification

Nice-to-have

  • Strong collaboration with investigators
  • Experience with protocol deviations
  • Audit preparation and inspection support
  • Effective participant relationship management
  • Proficiency in study documentation systems

Key Requirements

  • Knowledge of FDA and ICH GCP guidelines
  • Ability to manage Investigator Site Files
  • Experience with adverse event reporting
  • Proficiency in informed consent documentation

Work Rights

Not specified

Tailored Resume

Cover Letter