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Regulatory Coordinator II - Study Activation (Remote Option)

Company: Cedars-Sinai
Location: Beverly Hills
Posted on: September 24, 2022

Job Description:

Regulatory Coordinator II - Study Activation (Remote Option)Highly qualified candidates, residing in California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia, will be considered for remote work.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 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, attending 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, action plans to 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). --- Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. --- 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. --- Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials. --- Meets with monitors from pharmaceutical companies and represents the Medical Center during these meetings. --- 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. --- May provide training and education of other personnel. --- May participate in centralized activities of the department or institution. --- May plan and 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. --- 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.

  • Education: Bachelor of Arts/Bachelor of Science degree required.
  • Licenses: -ACRP/SOCRA -certification preferred.
  • Experience: Three years -minimum of directly related experience, or equivalent combination of education and experience.

Keywords: Cedars-Sinai, Beverly Hills , Regulatory Coordinator II - Study Activation (Remote Option), Other , Beverly Hills, California

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