Purpose Statement / Position Summary

The Regulatory Affairs Coordinator I will assist the clinical study team(s) with the administration and regulatory compliance of clinical research. Responsibilities will include regulatory preparation, maintenance and support for MemorialCare clinical research protocols. Projects may include industry-sponsored, federally-funded, and/or investigator-initiated studies.

Essential Functions and Responsibilities of the Job

• Work with principal investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with Food and Drug Administration (FDA) and local Institutional Review Board (IRB) policies.  
• Assure all site documents, including SOPs and administrative files, are maintained in audit-ready condition.
• Remain informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.
• Be at work and be on time.
• Follow company policies, procedures and directives.
• Interact in a positive and constructive manner.
• Prioritize and multitask.