Job Description

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

About the Team

This position will provide support to the Endocrinology Division in our Department of Medicine under the direction of Dr. Anat Ben-Shlomo. Dr. Ben-Shlomo is an endocrinologist specializing in adrenal and pituitary diseases, with clinical practice in this field since 2000. Her research spans both clinical and translational-basic science, focusing on disorders of the pituitary gland and adrenal glands. Her work bridges bench and bedside, striving to advance understanding and treatment of these complex endocrine conditions.

About the Role

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. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

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.
• 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.
• 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 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.

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:

• 2 years of clinical research experience is required.