Clinical Research Associate I

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 a clinical study. The role involves evaluating and abstracting research data, ensuring compliance with protocol and research objectives, completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB. This position provides limited patient contact as needed for the study, assists with study budgets and patient research billing, and ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations.

Key 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) including submission of Adverse Events, Serious Adverse Events, and Safety Letters.
• 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.

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.