TI Sr Clinical Research Associate

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:

 

IRB Protocol Management and Development

• In collaboration leadership and based on sponsor protocol, develop and submit new IRB protocols for review.
• Work in collaboration with coordinator teams and leadership to ensure timely closeout of all IRB protocols covering studies that have terminated
• Work in collaboration with coordinator teams and leadership to ensure all IRB protocols are up to date, including updated staffing information, accurate term dates, and that amendments and continuing reviews are submitted timely when adjustments are needed.
• Be the primary point of contact for IRB. Collaborate with study teams and leadership to submit changes, and address regulatory gaps with IRB protocols.

Study Documentation

• Monitor and ensure documentation storage meets FDA, institutional and sponsor guidelines.
• Oversight and maintenance of all regulatory binders for each study
• Ensure proper filing of all study correspondence between study team and sponsor for audit purposes
• Ensure proper filing of all correspondence between IRB and study team for audit purposes
• Ensure centralized documentation of all training certificates and medical license (if applicable) for study site staff and investigators for audit purposes
• Ensure centralized documentation of all monitor visit reports.  This includes site selection, site initiation, monitoring visits, and close-out reports
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Audit Support/Preparation

• Will develop in collaboration with leadership standardized auditing processes that includes a consistent methodology across all trials and allows for all critical components of study conduct to be reviewed.
• In collaboration with leadership, identify at risk trials and perform an in-depth internal review.
• Provide standardized reporting of all relevant findings, including possible action items and areas for retraining or process changes.
• Learn FDA audit practices and work to identify and create strategies towards FDA audit in collaboration with leadership.

Monitoring Visits

• Work with the study teams to schedule and organize any documentation or data entry needed prior to the monitoring visit
• Meet and provide any needed information or data to the monitor during the visit
• Assist study teams in addressing any key deficiencies identified during a site monitoring visit. Provide report out to leadership on next steps.
• Ensure all docu