Regulatory Maintenance Specialist — Hybrid, Audit-Ready

Adams Clinical, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 60,000 - 75,000; Full time

Benefits offered by this job

401(k) matching

Employee assistance program

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Job summary

Adams Clinical, a leading clinical trial site network, is seeking a Regulatory Maintenance Specialist in Philadelphia to own regulatory matters from activation through closeout. You will manage IRB approvals, staff credentialing, and ensure ongoing inspection readiness while partnering with site operations.

This onsite role offers occasional work-from-home days, a collaborative team, and a strong focus on data quality and participant safety.

Qualifications

• 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.

Responsibilities

• 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 approvals, amendments, and ICF updates, and verify staff are informed before activities proceed.
• Complete regulatory onboarding for new staff and track licenses, certifications, and training expirations.

Skills

Regulatory maintenance

IRB approvals & amendments

GCP knowledge

Regulatory onboarding

Attention to detail

Education

Bachelor's degree in life sciences/clinical research

Tools

CRIO/eReg/eSource

Job description

Adams Clinical, a leading clinical trial site network, is seeking a Regulatory Maintenance Specialist in Philadelphia to own regulatory matters from activation through closeout. You will manage IRB approvals, staff credentialing, and ensure ongoing inspection readiness while partnering with site operations.

This onsite role offers occasional work-from-home days, a collaborative team, and a strong focus on data quality and participant safety.