Cedars-Sinai Clinical Research Coordinator II - CTSI/CTRC in Los Angeles, California
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements. Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of researchers develop some of the most advanced clinical trials in the world. Here, you will be a part of leading-edge cancer research history that improves and enhances our patients' treatment options, one trial at a time.
Do you have a passion for helping human kind?
As Clinical Research Coordinator (CRC) II, you will provide 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. Your work will support our mission of rapidly translating research discoveries into safe, effective treatments.
You will work in collaboration with Clinical Research Associates, Research Program Administrators and Research Nurse Coordinators.
As a CRC II, you will also be responsible for the following:
Working with the physician and other medical personnel, you will document changes in patient conditions, adverse events, concomitant medication use, protocol compliance, response to study drug.
Works independently providing study coordination, including the screening of new research participants.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedule patients for research visits and procedures and participate in monitoring and auditing activities
Accountable 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.
Work closely with a regulatory coordinator or directly with (IRB) to submit adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in conjunction with local and federal guidelines.
Be involved with other regulatory duties such as: budgeting duties and assisting with patient research billing and reconciliation.
Plan and coordinate strategies for increasing patient enrollment.
You will ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
You will maintain research practices using Good Clinical Practice (GCP) guidelines and maintain strict patient confidentiality according to HIPAA regulations and applicable law
Four (4) years minimum of directly related experience required
ACRP or SoCRA (or equivalent) certification preferred.
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
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.