Clinical Research Regulatory Specialist

Job Summary

To support the execution of clinical studies, the part-time Clinical Research Regulatory Specialist will manage day-to-day regulatory tasks, including IRB submissions and regulatory documentation, while working remotely.

Key responsibilities:

• Perform startup activities including IRB submissions and regulatory documentation
• Assist with the management of the eRegulatory platform, including creating study binders and monitoring investigator credentials
• Complete and route regulatory documentation to research staff and investigators for signatures

Required qualifications:

• High school diploma required; bachelor's degree preferred
• 1-2 years of clinical research experience with a focus on regulatory and QA
• Current GCP certification
• Sound knowledge of ICH/GCP and FDA regulatory requirements
• Proficiency in Microsoft Office, Microsoft Excel, and Adobe Acrobat