Clinical Research Associate I

4 weeks ago

Beverly Hills, United States Cedars-Sinai Full time

Principal Investigator, Wei Gao, PhD is looking for a Clinical Research Associate to join the team

When the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai, and it’s just one of the many reasons why we rank as one of the top hospitals in the nation by . News & World Report.

Are you ready to be a part of breakthrough research?

The Gao Laboratory focuses on better understanding the neurophysiological mechanisms underlying normal/abnormal human brain development and adult brain functioning. We use advanced neuroimaging technologies (MR, PET, combined with biological, behavioral and neuropsychological testing to probe the central question of how our brain develops and functions under both normal and abnormal conditions. The ultimate goal of the Gao Laboratory is to foster better brain development and help cure brain disorders using imaging guidance. To learn more, please visit:

We are seeking a Clinical Research Associate I (CRAI) who will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. The CRAI evaluates and abstracts research data and ensures compliance with protocol and overall clinical research objectives. This role is responsible for completing case report forms (CRFs) and entering clinical research data, as well as providing limited contact with research participants as needed for study and assists 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 & Responsibilities:

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.

Education:

High School Diploma/GED is required. Bachelor's degree preferred in Science, Sociology, or related field.

Experience and Skills:

Understanding of​ general clinical research objectives. Clinical research experience is preferred. Ability to interpret and apply knowledge of State, Federal, and Agency standards to comply with regulations. Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

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