Clinical Trials Regulatory Steward

Adams Clinical, Inc.; Watertown (MA); On-site; 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 seeks a Regulatory Maintenance Specialist for the Watertown site. This on-site role maintains regulatory compliance and inspection readiness from activation through closeout, partnering with site operations to protect data quality and participant safety.

The role manages IRB approvals and staff credentialing, resolves sponsor/CRA items, and ensures audit readiness with central start-up support and regular team meetings.

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

• Distribute IRB approvals, amendments, and ICF updates and inform staff before activities proceed.
• Submit continuing reviews and other required reports to the IRB within timelines.
• Maintain version control so current ICFs and study documents are in use.

Skills

Regulatory knowledge

Attention to detail

GCP familiarity

IRB processes

Communication

Education

Bachelor's degree in life sciences/clinical research

Tools

CRIO eReg

eReg/eSource systems

Job description

Adams Clinical seeks a Regulatory Maintenance Specialist for the Watertown site. This on-site role maintains regulatory compliance and inspection readiness from activation through closeout, partnering with site operations to protect data quality and participant safety.

The role manages IRB approvals and staff credentialing, resolves sponsor/CRA items, and ensures audit readiness with central start-up support and regular team meetings.