Clinical Research Associate I - Heart Institute

Benefits

Qualifications

• •High School Diploma is required

Responsibilities

• •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
• •Evaluates and abstracts research data and ensures compliance with protocol and research objectives
• •Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB
• •Provides limited patient contact as needed for study and assist with study budget and patient research billing
• •Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care
• •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) that the sponsors provide
• •Provides supervised patient contact or patient contact for long term follow-up patients only
• •Assists 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
• •Assists with clinical trial budgets
• •Assists with patient research billing
• •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
• •17 more items(s)