Heart Institute - Clinical Research Associate I, Susan Cheng Team

About the Role

The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives at the Smidt Heart Institute, a leader in heart disease treatment and research innovation.

Responsibilities

• Works with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate/implement study.
• Evaluates and abstracts clinical research data from source documents.
• Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) provided by sponsors.
• Provides supervised patient contact or patient contact for long-term follow-up patients only.
• Assists with regulatory submissions to the Institutional Review Board (IRB) and submits Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Assists with clinical trial budgets and patient research billing as needed.
• Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping, and maintenance of study supplies and kits.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Requirements

• High School diploma/GED required; BA/BS degree in Science, Sociology, or related field preferred.
• Understanding of general research objectives.
• 1 year of clinical research-related experience preferred.
• Excellent language skills and understanding of Grants, Manuscript, and Abstract guidelines.
• Strong verbal and written communication skills, along with computer, organization, personnel, and time-management skills.
• Proficiency in Word, PowerPoint, and Excel.
• Ability to work independently, set priorities, and handle multiple tasks requiring attention to detail.
• Previous experience in a research environment preferred.

Physical Demands

• Able to perform moderate lifting.
• Able to sit, stand, and walk for prolonged periods of time.
• Able to read papers and online documents.
• Able to operate standard office equipment.
• Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.