Clinical Research Associate I - Heart Institute - Berman Lab

Primary Duties & 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.
• Safeguards compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs).
• Enters clinical research data into Electronic Data Systems (EDCs) that the sponsors provide.
• Provides supervised patient contact or patient contact for long term follow-up patients only.
• Affords assistance with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
• Affords assistance with clinical trial budgets.
• Affords assistance with patient research billing.
• Schedules patients for research visits and research procedures.
• Maintains responsibility for sample preparation and shipping and maintenance of study supplies and kits.
• Maintains compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Qualifications

• Education: High School Diploma is required. Bachelor's degree is preferred in Science, Sociology, or a related field.
• Experience and Skills: One (1) year of clinical research related experience is preferred.