Department Overview:
The Knight Cardiovascular Institute Clinical Research Associate is responsible for various duties supporting clinical trials focused on the investigation of new drug, infusion, and gene therapies for treating patients with cardiac diseases including, hypertrophic cardiomyopathy, amyloidosis, and others encompassing an array of heart failure disease phenotypes supporting the Cardiomyopathy research team directed by Dr. Masri. This position will have a strong understanding of the principles of clinical research and the regulatory responsibilities integral to the success of the work; they will be available to all coordinators and assistant coordinators for triaging daily questions.
The position is on point for all regulatory work, organizing and leading monitoring visits with sponsors, preparation and execution of activities needed during an FDA audit, and working with leadership on projects relating to study start-up. They also serve as a mentor to junior research staff in the group, is on point for collaborating with leadership in organizing the training and onboarding of new coordinators within the group, as well as developing standardized workflows and SOP’s for the program. Lastly, this position is also responsible for analyzing and interpreting complex research data and assisting the principle investigator in publication development.
The Clinical Research Associate is the primary liaison for patients receiving experimental research procedures on a clinical trial and is responsible for the triage of patient needs and identification, reporting of, and follow-up of adverse events. They have a strong understanding of the connection and differences between clinical care and protocol visits conducted for research subjects. This position will primarily support our Hypertrophic Cardiomyopathy and Amyloid research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute. This is an onsite role with limited hybrid opportunities.
Function/Duties of Position:
The Senior Coordinator oversees all regulatory activities for each study in the program. This includes the following:

Please refer the Job description for details