Clinical Research Coordinator II – Translational Research Unit – Rheumatology

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

The Division of Rheumatology at Cedars-Sinai has established a comprehensive clinical and translational research program.

This involves a streamlined infrastructure (Translational Research Unit or TRU) to support prospective cohorts of patients affected by rheumatic diseases such as scleroderma, systemic lupus erythematosus and rheumatoid arthritis, as well as participation in ground breaking clinical trials.

Dr. Francesco Boin is a physician-scientist with extensive experience in the diagnosis and treatment of scleroderma and other fibrosing skin disorders.

His research is focused on the genetic risk of scleroderma and the biology of immune cells involved in the pathogenesis of this disease.

The Clinical Research Coordinator II works independently providing study coordination including screening of patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.

The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.

The team member in this position will work closely with Scleroderma Program and Rheumatology faculty investigators to harmonize clinical research and clinical care efforts by streamlining workflows as needed in the context of dynamic clinical setting.

Primary Duties and Responsibilities :

• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following;

changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

• Maintains accurate source documents related to all research procedures.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information;

present this information at regular research staff meetings.

• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
• 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 coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• May plan and coordinate strategies for increasing patient enrollment, and / or improving clinical research efficiency.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• May identify new research opportunities and present to investigators
• Participates in required training and education programs.

Education :

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

Licenses / Certifications :

ACRP / SoCRA certification is preferred.

Experience :

Two years of clinical research experience, required.

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