Clinical Research Associate I - Alzheimer's and Dementia Program - Department of Neurology (Hybrid)

Cedars-Sinai • Los Angeles, CA • 3h ago

Job Description

Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!

Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.

Dr. Zaldy Tan invites you to consider this Clinical Research Associate I opportunity to join his dynamic team!

About the Team

The research of Dr. Tan focuses on brain health, Alzheimer's disease, and health services optimization for older patients. Dr. Tan's studies on brain aging and memory have been published in major medical journals and featured in the New York Times, Time, CNN, Wall Street Journal, Washington Post, and other national publications.

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 the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for 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.

This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired, you must reside in the commutable area.

Primary Job Duties and Responsibilities:

Collects, evaluates and/or abstracts clinical research data.

May assist in designing forms for data collection/abstraction.

Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.

Completes Case Report Forms (CRFs).

Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.

Assists supervising staff 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 and patient research billing.

Responsible for sample preparation and shipping and maintenance of study supplies and kits.

Ensures compliance with protocol and overall clinical research objectives.

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.

May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attends meetings regarding study activity under the direction of supervising staff.

Department-Specific Duties:

Transportation of research medications.

Performs study related assessments and questionnaires.

Maintains organized paper and electronic research files.

Assists with preparing manuscripts, letters, and other research documents as needed.

Performs literature reviews.

Qualifications

Education, Experience, and Skills:

High School Diploma/GED is required.

Clinical research experience is preferred.

Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.

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