Clinical Trials Coordinator II - Regulatory & Operations

Cedars-Sinai; Los Angeles (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Cedars-Sinai is seeking a Clinical Research Coordinator II to support regulatory and operational aspects of clinical trials, focusing on screening, consent, data collection, and reporting while ensuring adherence to FDA, IRB, and sponsor requirements.

You will coordinate enrollment, maintain source documentation, and contribute to trial integrity in a highly regulated environment, collaborating with investigators and study teams.

Qualifications

• High School Diploma/GED
• 2 years of clinical research-related experience

Responsibilities

• Screening participants for protocol eligibility
• Supporting the informed consent process
• Maintaining accurate source documentation related to research visits
• Coordinating protocol-defined enrollment activities and timelines
• Supporting Adverse Event (AE) and Serious Adverse Event (SAE) documentation and reporting related to participant safety
• Helping ensure research activities remain compliant with FDA, OHRP, IRB, sponsor, and protocol requirements
• 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
• Documents thoroughly on Case Report Forms (CRFs) 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
• Notifies supervisor about concerns regarding data quality and study conduct
• Works with IRB to submit AE/SAE deviations and safety letters
• Maintains HIPAA-compliant patient confidentiality
• May coordinate training and education of staff
• May participate in auditing and SOP development
• May plan strategies for increasing patient enrollment and improving efficiency
• May identify quality and performance improvement opportunities and collaborate on action plans
• May identify new research opportunities and present to investigators
• Participates in required training and education programs

Education

Bachelor’s Degree in Science, Sociology, or a related field

Job description

Cedars-Sinai is seeking a Clinical Research Coordinator II to support regulatory and operational aspects of clinical trials, focusing on screening, consent, data collection, and reporting while ensuring adherence to FDA, IRB, and sponsor requirements.

You will coordinate enrollment, maintain source documentation, and contribute to trial integrity in a highly regulated environment, collaborating with investigators and study teams.