Clinical Research Regulatory Specialist

The role

The Clinical Research Regulatory Specialist serves as the regulatory owner for the Bronx site. This person manages IRB approvals, maintains staff credentialing, and ensures continuous audit readiness for active studies.

What you will do

• Distribute IRB approvals, amendments, and ICF updates
• Submit continuing reviews, protocol deviations, and required reports to the IRB
• Maintain version control for ICFs and study documents
• Complete regulatory onboarding for new staff
• Track licenses, certifications, and training expirations
• Maintain regulatory binders and study files in CRIO eReg
• Resolve sponsor and CRA action items from monitoring visits
• Submit IRB termination reports and complete closeout documentation
• Coordinate records retention and archiving
• Partner with the central start-up team and participate in team meetings

Required qualifications

• Bachelor's degree in life sciences, clinical research, or a related field
• 1-2 years of clinical trial experience
• Working knowledge of GCP and IRB processes
• Strong written and verbal communication skills with PIs, sponsors, CROs, and site teams
• Collaborative and respectful approach to working with site staff and colleagues
• Results-driven and able to adapt as priorities shift
• Detail-oriented and thorough

Nice to have

• regulatory experience
• familiarity with FDA regulations and 21 CFR Part 11
• Experience with eReg or eSource systems
• CRIO

Benefits

• 401(k) matching
• Medical, Dental, & Vision insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance

Before you apply

• Must provide documentation verifying identity and authorization to work in the United States
• Must complete Form I-9 within the required time frame

About the company

Adams Clinical is a clinical trial site network. Their mission is to deliver data quality, safety, and diverse enrollment to advance healthcare.