Job Description

Join us as we translate today's discoveries, into tomorrow's medicine!

Regenerative medicine is a new and developing field that strives to restore function in diseased or aged tissues through either revitalizing existing cells or transplanting new ones. At the Board of Governors Regenerative Medicine Institute, researchers are turning stem cells into therapies for treating a multitude of prevalent diseases and conditions. We're also exploring how to prevent diseases, and we're extending our knowledge to students in Los Angeles and researchers around the world. To learn more, please visit Board of Governors Regenerative Medicine Institute | Cedars-Sinai

Are you ready to be a part of breakthrough research?

The Clinical Research Associate I will work 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. Additionally, this position will include animal work (injections, dissections, and surgery), sample processing, and cell culture.

Primary Job Duties and Responsibilities:

• 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.
• 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:

• Performs data searches and other related administrative tasks.
• Assists with research protocol writing and development.
• Transportation of research medications.
• Performs study related assessments and questionnaires.
• Assists with prescreening of potential research participants for various clinical trials.
• Maintains organized paper and electronic research files.
• Performs all data collection and data entry tasks for department clinical trials.
• Assists with preparing manuscripts, letters, and other research documents as needed.
• Responds to sponsor? inquiries regarding protocol start-up activities and recruitment.
• Performs literature reviews.
• Attends research meetings and monthly conference calls with sponsors for study updates.
• Performs cell culture, immunohistochemistry including processing of samples.
• Performs animal injections, dissections and surgery.
• Assists with scheduling of visits and assessments.

Qualifications

Education:

• High School Diploma or GED is required.

Experience and Skills:

• Clinical Research related experience is preferred.
• Ability to interpret and apply knowledge of State, Federal, and Agency standards to follow regulations.
• Must possess digital literacy, including Word and Excel, and the ability to use standard office equipment is required.

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About Cedars-Sinai Medical Center

Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competi...tive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.

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