Clinical Research Coordinator II - Cancer Clinical Trials Office
Requisition # HRC0375359
The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer, including its medical network and health system, which at any given time has approximately 140 cancer clinical trials. CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout. We are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.
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; present this 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).
Additional duties and responsibilities:
- 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.
- Scheduling of 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.
- 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.
- Responsible 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.
- Notifies 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 involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
- 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 plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
- 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.
- ACRP/SoCRA (or equivalent) certification preferred.
- Four (4) years minimum of clinicial research coordination experience, required.
- Working Title: Clinical Research Coordinator II - Cancer Clinical Trials Office
- Department: SOCCI Clinical Research Office
- Business Entity: Academic / Research
- City: Los Angeles
- Job Category: Academic/Research
- Job Specialty: Research Studies/Clinical Trials
- Position Type: Full-time
- Shift Length: 8 hour shift
- Shift Type: Day
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. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.
At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu). For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through March each year) as a condition of employment, and annually thereafter as a condition of continued employment.
About Our Location
Los Angeles, California