Clinical Research Associate I - MIRIAD IBD Biobank & Database (Los Angeles)

Job Description

Are you a passionate and dedicated research professional?

CedarsSinai IBD Institute is an international leader in the science and treatment of IBD. The IBD Institute has brought together the largest community of medical and scientific leaders to research the biology of IBD and discover intervention and prevention strategies. Our experts aim to provide enduring, precision treatment to patients around the world.

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.

Department-Specific Duties and Responsibilities :

Qualifications

Education :

Licenses and Certifications :

Experience and Skills :

About Us

Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.

About the Team

Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.

Req ID : 11914

Working Title : Clinical Research Associate I - MIRIAD IBD Biobank & Database

Department : Research - Digestive and Liver Diseases

Business Entity : Cedars-Sinai Medical Center

Job Category : Academic / Research

Job Specialty : Research Studies / Clin Trial

Overtime Status : NONEXEMPT

Primary Shift : Day

Shift Duration : 8 hour

Base Pay : $19.50 - $32.86