Regulatory Coordinator - 234444
Medixâ„¢ - glendale, AZ
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Job Title: Regulatory CoordinatorLocation: Glendale, CA (91204)Hours: Monday - Friday, 9am-4pmPay: $35 - $47hourOverview:We are seeking a highly organized and experienced Regulatory Coordinator to manage the submission of regulatory documents to central IRBs. The role will encompass both study start-up processes and ongoing maintenance of regulatory files. This is a pivotal position during an exciting transition as this organization moves from paper documentation to a cutting-edge eReg system, eFlorence, where all regulatory documents will be managed electronically with electronic signatures.Key Responsibilities:Prepare and submit all necessary regulatory documents to central IRBs for study initiation and maintenance.Ensure compliance with regulatory requirements, maintaining accurate and up-to-date regulatory documentation.Collaborate with internal teams to bring together and organize multiple regulatory binders (4 binders) in preparation for the implementation of the new eReg system.Support and guide the transition to eFlorence and become proficient in using the electronic signature systems.Manage regulatory processes for multiple studies simultaneously (15-20 studies).Maintain a high level of organization in a rapidly evolving environment with minimal structure during the transition period.Must-Have SkillsQualifications:EducationExperience:2-3 years of regulatory experience with a Bachelor's degree, or 3-4 years without.Central IRB Expertise: Extensive experience in submitting regulatory documents to central IRBs.Multi-Study Management: Proven ability to balance 15-20 studies at a time.eReg System Experience: Familiarity with any electronic regulatory system.Adaptability: Comfortable working in a dynamic, less structured environment during the system transition.Nice-to-Have SkillsQualifications:Experience in regulatory affairs for Oncology clinical trials.Familiarity with Phase I vaccine trials involving multiple investigators.Hands-on experience with eFlorence.Background in drafting amendments, though not required, this experience would be highly valuable.This position offers an opportunity to play a critical role in the operational efficiency of regulatory processes while contributing to a smooth transition into a fully electronic regulatory system.
Created: 2024-09-30