Regulatory Coordinator I -CCTO

Requisition # HRC1067925

The Cedars-Sinai Cancer Research Team is committed to pursuing groundbreaking research into disease method, diagnostic innovations, new technologies, and resources. Through our historic achievements, growing research enterprise, and serving one of the most diverse regions in the world, we have physicians and scientists that are uniquely positioned to guide the next generation of progress against the disease!

Would you like to be a part of an innovating team? We look forward to having you join our team and use your skills with an organization known nationally for excellence in cancer research!

The Regulatory Coordinator I will prepare and submit protocols and supporting documents to regulatory bodies such as PPC,PRMC, IBCS, Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process. This role submits continuations, amendments, responds to questions, generates reports, and maintains files,
research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include,
representing the Research Department when meeting with phamaceutical companies, attending weekly team meetings, and
working with other staff to insure all regulatory documents and requirements are up-to-date. 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:

• Prepares and submits protocols and supporting documents to regulatory bodies such as PPC, PRMC, IBCS (if needed),
Cedars-Sinai IRB, Third Party IRB (WIRB) and any research committee involved in the Pre-Award/Post-award process.
• Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and
institutional policies.
• Completes forms and generates all reports necessary to align with regulatory requirements and institutional policies.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
• Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents
for the research studies are up-to-date.
• Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and
amendments. 

Educational Requirements:

Bachelor’s Degree

Experience:

1 year Research  related experience required. 

Working Title:Regulatory Coordinator I -CCTO
Department:SOCCI Clinical Research Office
Business Entity:Academic / Research
Job Category:,Compliance/Quality,Compliance/Quality
Job Specialty:Research Compliance
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) and COVID-19. 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 April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.

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