Clinical Research Coordinator I - Dept of Orthopaedics

• Align yourself with an organization that has a reputation for excellence!
• Cedars-Sinai was awarded the National Research Corporation’s Consumer Choice Award 19 years in a row for providing the highest-quality medical care in Los Angeles.
• We were also awarded the Advisory Board Company’s Workplace of the Year.
• This recognizes hospitals and health systems nationwide that have outstanding levels of employee engagement.
• We offer an outstanding benefits package and competitive compensation.
• Join us!
• Discover why U.S.
• News & World Report has named us one of America’s Best Hospitals.

What you be doing in this role

• The Clinical Research Coordinator I works independently providing study coordination, screening of potential 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 study information at regular research staff meetings.
• 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

Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

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.

Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

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.

Participates in required training and education programs.