About this role

responsible for calling potential candidates that pre-qualify for clinical research to schedule a screening visit
using protocol and other guidelines to generate a Source Document to gather data needed for the clinical trial
performing all clinical trial activities and assessments per ICH and FDA regulatory guidelines
collecting vital signs, providing surveys to the clinical trial subject
contributing to the regulatory binder by providing necessary forms requested for compliance with ICH, GCP and FDA guidelines

Bachelor's degree in a related field -OR
equivalent combination of education and experience
Human subjects protections training
knowledge of the Code of Federal Regulations
GCP (Global Good Clinical Practice)
ICH (International Council for Harmonization) Guidelines as applied to clinical trials
IRB and other regulatory processes and procedures
including HIPAA
Shipping biohazard materials certification preferred
Current certification in clinical research is preferred
Strong working knowledge in Microsoft Office programs and other software packages
Medical and research terminology, processes and procedures
phlebotomy experience
ECG training and training in other clinical procedures
general knowledge of infection control procedures

Clinical Research Coordinator I

Key skills