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Cedars-Sinai Cancer is committed to pursuing pioneering research into disease mechanism, diagnostic innovations and new technologies and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, our physicians and scientists are uniquely positioned to guide the next generation of progress against the disease.
Join our team and use your expertise with an organization known nationally for excellence in cancer research!
The Clinical Research Coordinator II works 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. 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 information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. 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
- 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.
- Schedules and participates in monitoring and auditing activities.
- Advises 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.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May coordinate training and education of other personnel.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- May identify new research opportunities and present to investigators
- Participates in required training and education programs.
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Requirements:
- High School Diploma/GED required
- 2 years Clinical research related experience required
Preferred:
- SOCRA or ACRP certification preferred
- Bachelor’s Degree Science, Sociology or related degree preferred
Working Title: Clinical Research Coordinator II – Cancer Clinical Trials Office
Department: SOCCI Clinical Research Office
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$64,500.00 – $100,000.00