About this role

Conduct regulatory activities for clinical trials in the Lombardi Clinical Trials Office.
Prepare, maintain, and coordinate regulatory submissions and documentation.
Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials.
Create and revise informed consent documents and other regulatory documentation.
Submit applicable documents to study sponsors as required.
Organize study regulatory files including regulatory submissions and trial communication.
Participate in study activation management activities ensuring accuracy and completeness.
Effectively communicate trial status and updates to team members and external personnel.
Assist with compiling regulatory-related metrics for use by senior management.
Prepare for and participate in trial site initiation visits and audits.

Bachelor’s Degree in a science related field required.
Three to five (3-5) years regulatory affairs or clinical research experience required.
SoCRA, ACRP, RAPS, or CIP certification preferred.
Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice
Excellent verbal and written communication skills, organizational skills, and attention to detail.
Reliability and ability to prioritize competing responsibilities.

Regulatory Associate I

Key skills