The Clinical Research Coordinator is responsible for coordinating daily clinical trial activities in partnership with the principal investigator and physician practice
Job Summary
The Clinical Research Coordinator is responsible for coordinating daily clinical trial activities in partnership with the principal investigator and physician practice.
The role requires ensuring strict adherence to Study Protocols, FDA regulations, ICH guidelines, and protecting the rights and safety of study participants.
Key duties include managing participant care from screening through completion, maintaining essential documents, and processing patient stipend payments.
Matching Summary
The Clinical Research Coordinator is responsible for coordinating daily clinical trial activities in partnership with the principal investigator and physician practice.
Skills & Requirements
Must-have
Coordinate daily clinical trial activities
Ensure informed consent process compliance
Maintain source records and documentation
Report adverse events and protocol deviations
Adhere to FDA and HIPAA regulations
Manage investigational product dispensing
Nice-to-have
Foster patient-care culture emphasizing safety
Promote team effort and collaboration
Develop effective relationships at all levels
Provide training to research assistants
Maintain industry standard licensures
Key Requirements
Knowledge of FDA Federal Code Regulations
Understanding of Good Clinical Practice (GCP)
HIPAA Privacy Rule compliance knowledge
Ability to travel between facilities
Maintain industry standard licensures and certifications