Clinical Research Associate I - OBGYN - Accortt Research Team - Per Diem, Hybrid

Come join our team!

• 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.

• Primary Duties and 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) that are provided by the 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 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.