Regulatory Coordinator

Job Title: Regulatory Coordinator

Location: Glendale, CA (91204)

Hours: Monday - Friday, 9am-4pm

Pay: $35 - $47/hour

Overview:

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 Skills/Qualifications:

• Education/Experience:
• 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 Skills/Qualifications:

• 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.