Cedars-Sinai Clinical Research Coordinator I - Cancer Clinical Trials Office in Los Angeles, California
At Cedars-Sinai, we're motivated by a collective spirit of innovation and the challenge to continuously improve. Above all, we share a real passion for helping others. Day after day, from department to department, our people give their all to create a community unlike any other. This is just one of the many reasons U.S. News & World Report has named us one of America’s Best Hospitals—and now we invite you to join us and make a difference every single day in service of this outstanding work – excellence and innovation in patient care, research, and community service. From working with a team of dedicated professionals to using state-of-the-art facilities, you’ll have great resources to do something incredible—for yourself, and for others!
Essential Job Duties:
As Clinical Research Coordinator (CRC) I, you will work independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. You will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
As a Clinical Research Coordinator I, you will also be responsible for the following:
Compile and report on each study including information related to protocol activity, accrual data, workload, and other research information
Document thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintain accurate source documents related to all research procedures.
Schedule patients for research visits and procedures.
Schedule and participate in monitoring and auditing activities.
Notify direct supervisor about concerns regarding data quality and study conduct.
Work with regulatory coordinators 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 assist with other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Maintain research practices using Good Clinical Practice (GCP) guidelines.
Maintain strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
- BA/BS degree, required.
- ACRP/SoCRA (or equivalent) certification, preferred.
- Two (2) years of directly related experience, required.
Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.