JOB SUMMARY:

Under supervision, the Clinical Research Coordinator will be assigned to assist with multiple clinical research studies involving human subjects within the research unit/department. Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis on pediatric clinical research studies. Responsibilities may include initiating & managing multiple research projects, including but not limited to clinical trials, PI-initiated studies, and other research projects. Responsibilities may include but are not limited to: submission of protocols & renewals to IRB & scientific review boards; management & submission of electronic data forms to Sponsors, CROs & regulatory agencies; screening for eligibility; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data management activ...