Summary:

What You’ll Do

In this role, you will support a portfolio of clinical research studies while helping elevate the work of those around you.

Lead and support regulatory activities for clinical trials, from startup through closeout

Prepare and submit study documents such as new protocols, amendments, and continuing reviews
Ensure compliance with FDA regulations and Good Clinical Practice (GCP) standards
Partner with investigators, sponsors, and internal teams to keep studies on track
Review regulatory documentation for accuracy, completeness, and timeliness
Mentor and train team members, sharing best practices and building team capability
Identify opportunities to improve processes and drive more efficient, compliant ways of working
Act as a change champion, helping teams adopt new tools and approaches


What You’ll Bring

We’re looking for someone who combines regulatory expertise with a...