Primary Duties and Responsibilities:

Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents 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. 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. Participates in required training and education programs.

Qualifications 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:

One year of clinical research experience, required. 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 915 licensed beds, 2,993 physicians, 4,700+ nurses and thousands of other healthcare professionals and staff. 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Clinical Research Coordinator I - Medically Associated Science & Technology (MAST) Program