Regulatory Maintenance Specialist

Adams Clinical•New York, NY

33d•$60,000 - $75,000•Hybrid

About The Position

The Regulatory Maintenance Specialist serves as the regulatory owner for the Bronx 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. The Regulatory Maintenance Specialist is responsible for managing IRB approvals and amendments, maintaining staff credentialing and delegation, resolving sponsor and CRA action items, and sustaining continuous audit readiness. Reporting to the Central Regulatory Maintenance Manager, this position partners with site staff, PIs, sponsors, and CRAs, and collaborates with regulatory colleagues across our six-site network. Supported by twice weekly team check-ins, monthly regulatory meetings, and centralized study start-up support, the role is measured against specific goals tied to performance bonuses. This is an onsite position with potential for a couple of work-from-home days.

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Detail-oriented and thorough, catching discrepancies such as outdated ICF versions and confirming documents are filed and communicated to the right people.

Nice To Haves

regulatory experience preferred
familiarity with FDA regulations and 21 CFR Part 11 preferred
Experience with eReg or eSource systems preferred (CRIO a plus)

Responsibilities

Distribute IRB approvals, amendments, and ICF updates, and verify that site staff are informed before study activities proceed.
Submit continuing reviews, protocol deviations, and other required reports to the IRB within established timelines.
Maintain version control so only current, approved ICFs and study documents are in use.
Complete regulatory onboarding for new staff, including Form FDA 1572 updates, training logs, financial disclosure forms, and delegation of authority log entries.
Track licenses, certifications, and training expirations, and prompt renewals before they lapse.
Maintain regulatory binders and study files in CRIO eReg in a state of continuous audit readiness.
Resolve sponsor and CRA action items from monitoring visits, and respond to document requests, within established timelines.
Submit IRB termination reports, end staff delegation, and complete closeout documentation.
Coordinate records retention and archiving.
Partner with the central start-up team for a smooth handoff at study activation.
Participate in twice-weekly check-ins and monthly regulatory team meetings to share updates and best practices.