Cancer Center Jobs

Regulatory Coordinator II Study Activation (Remote Option)

Cedars-Sinai

May 10, 2022
Job title: Regulatory Coordinator II – Study Activation (Remote Option)

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!

Job Description:

The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC! 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 Medical Center when meeting with pharmaceutical companies, participating in weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, improve quality, and training and education of personnel. 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:

Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies
Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study
Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
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
Participate in weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments
May participate in centralized activities of the department or institution.
Coordinate strategies to improve existing standard operating procedures related to regulatory affairs
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
Maintains research practices using Good Clinical Practice (GCP) guidelines
Maintains strict patient confidentiality according to HIPAA regulations and applicable law

Education and Experience:

Bachelor's Degree required
Three (3) years minimum of directly related experience
Clinical research professional certification preferred

To apply

Regulatory Coordinator II - Study Activation (Remote Option) at Cedars-Sinai

Requisition # HRC0728229