Under supervision, the Clinical Research Coordinator will be assigned to assist with multiple clinical research studies involving human subjects that are being conducted within the RCHSD Heart Institute. Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA and all required regulatory guidelines, with an emphasis on pediatric clinical research studies.
Duties include but not limited to: interpreting research protocols; recruiting subjects; screening for eligibility; IRB and regulatory submissions; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data activities; processing and submitting laboratory specimens; collecting and entering research data; developing and maintaining a study data base; maintaining accurate and complete clinical research files and patient medical charts. Work directly with Human Research Protection Program (HRPP), submitting new protocol applications, amendments, safety reports and annual renewals as needed. Act as liaison between Principle Investigators, the HRPP and study sponsors as well as other departments within the Institution.
Two years of experience
Three years of experience
1-2 years clinical trials experience
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)