Clinical Research Coordinator I
4 weeks ago
At Cedars-Sinai, we are seeking a highly skilled Clinical Research Coordinator I to join our team. This role is responsible for providing study coordination, screening potential patients for protocol eligibility, and presenting non-medical trial concepts and details.
- Independent study coordination, including screening of potential patients for protocol eligibility and presenting non-medical trial concepts and details.
- Scheduling patients for research visits and procedures.
- Collaborating with physicians and medical personnel to document thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
- Maintaining 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.
- Scheduling and participating in monitoring and auditing activities.
- Compiling and reporting on each study, including information related to protocol activity, accrual data, workload, and other research information.
- Notifying direct supervisor about concerns regarding data quality and study conduct.
- Working 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.
- Maintaining research practices using Good Clinical Practice (GCP) guidelines.
- Maintaining strict patient confidentiality according to HIPAA regulations and applicable law.
- Participating in required training and education programs.
Qualifications
- High School Diploma/GED
- 6 months Clinical research related experience
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