This is a position for a Clinical Research Associate I in the laboratory of Dr. Katelyn Atkins, MD PhD. Dr. Atkins research focuses on the intersection of cancer and cardiovascular disease (cardio-oncology). Specifically, how baseline cardiovascular risk interacts with cancer treatment-associated cardiovascular toxicity (i.e., from radiation therapy, systemic therapies, chemotherapies) to identify novel strategies for improved surveillance and risk mitigation. The scope of her clinical research and collaborative team spans prospective clinical trials, retrospective cohort analyses, image processing, machine learning/artificial intelligence, and radiomics.

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 the Principal Investigator to perform a number of research activities.
• Assists in the logistics and regulatory aspects of clinical trials.
• 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

Requirements:

• High School Diploma/GED.
• Prior clinical research experience preferred.