Clinical Research Coordinator Iv

Fsmjobs

Gcp, ich, fda guidelines
Clinical study data collection
Protocol and timeline adherence
Works under the supervision of the Principal Investigator (PI) to support the conduct and management of a clinical study by facilitating and coordinating the daily study activities

Job Summary

  • Works under the supervision of the Principal Investigator (PI) to support the conduct and management of a clinical study by facilitating and coordinating the daily study activities.
  • Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines.
  • Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines.

Matching Summary

Works under the supervision of the Principal Investigator (PI) to support the conduct and management of a clinical study by facilitating and coordinating the daily study activities.

Skills & Requirements

Must-have

  • GCP, ICH, FDA guidelines
  • clinical study data collection
  • protocol and timeline adherence
  • patient phlebotomy procedures
  • site management organization system

Nice-to-have

  • leadership and mentoring capabilities
  • diplomacy and problem-solving skills
  • cost containment strategies
  • industry event representation

Key Requirements

  • Clinical Research Coordinator III or equivalent for 5+ years
  • Bachelor’s Degree; Advanced Degree preferred
  • Clinical Research Coordinator certification (CCRC or CCRP)
  • Current state licensure, if applicable
  • Ability to lift and carry up to 30 pounds

Work Rights

Not specified

Tailored Resume

Cover Letter