Role OverviewThe Regulatory Maintenance Specialist serves as the regulatory owner for the Philadelphia site, ensuring that every active study remains compliant and inspection ready from activation through closeout. This role combines hands on regulatory expertise with operational discipline, meticulous attention to detail, and close partnership with site operations to protect data quality and participant safety.
What You Will Do
Manage IRB approvals and amendments, maintain staff credentialing and delegation, resolve sponsor and CRA action items, and sustain continuous audit readiness.
Why It Might Be a Fit
This role is for someone passionate about making an impact in clinical research and wants to be part of a collaborative, mission-driven organization.
Requirements
- Bachelor's degree in life sciences, clinical research, or a related field
- 1-2 years of clinical trial experience; regulatory experience preferred
- Working knowledge of GCP and IRB processes; familiarity with FDA regulations and 21 CFR Part 11 preferred
- Experience with eReg or eSource systems preferred (CRIO a plus)
- Strong written and verbal communication skills with PIs, sponsors, CROs, and site teams
- Collaborative and respectful, with a kind, patient approach to working with site staff and colleagues, including under tight deadlines
- Results-driven, taking ownership, following through, and adapting as priorities shift
- Detail-oriented and thorough, catching discrepancies such as outdated ICF versions and confirming documents are filed and communicated to the right people
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
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