Heart Institute - Clinical Research Coordinator P/DSan Diego, California
Rady Children’s Heart Institute, an institute without walls, was created to integrate and coordinate the research and educational programs of the Cardiology and Cardiovascular Surgery divisions. Our goal is to provide optimal care for infants, children and adults with congenital heart defects and to advance our knowledge and understanding of congenital heart disease. We also care for patients with acquired heart disease.
Research, in affiliation with UC San Diego, is a major focus of our Institute. Our faculty and fellows are currently involved in over 65 ongoing research studies, which include clinical trials, to advance the understanding and application of pharmacological interventions, surgical procedures, electrophysiology procedures, advanced imaging and transcatheter interventions in the treatment of children and adults with congenital heart defects. We also facilitate basic and translational research and foster a culture of collaboration to ultimately improve care for those with congenital heart disease.
Under supervision, the Cardiology 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 & 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.
2 years of experience
3 years of experience
1 – 2 years of clinical trials experience
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
Bilingual skills (Spanish)