Job Description

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

About the Team

The MAST program at Cedars-Sinai Medical Center is dedicated to the development of novel drugs and devices to diagnose and treat patients. This innovative program is working to develop new diagnostics and therapeutics to treat patients with illnesses related to imbalances or alterations in the Microbiome. To learn more, please visit: https://www.cedars-sinai.org/research/areas/science-tech.html.

About the Role

The Clinical Research Coordinator I 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 is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. The CRC I team member is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents information at research staff meetings.

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.