The Clinical Research Manager for the ED is responsible for providing leadership and oversight of clinical research projects within the Division. The Clinical Research Manager will provide management of clinical research operations, including quality management, personnel management, and regulatory compliance. As well as collaborating with Principal Investigators and study coordinators for management of research studies within the Division. Acts as liaison between the Division and sponsors of the clinical research (eg. pharmaceutical companies, NIH, foundations) program and CMH Medical Research Administration as relates to day-to-day operations. Utilizes experiences and knowledge as a resource to enhance the research capabilities and accomplishments of the Division.
Applies knowledge of regulations, guidance's, and Good Clinical Practices (GCP), including the protection of human research subjects with particular emphasis on pediatrics, reporting requirement for adverse events, elements of informed consent, and other local laws, policies, and procedures that govern the performance and conduct of clinical research activities.