Regulatory Maintenance Specialist

Adams Clinical is a clinical trial site network focused on advancing healthcare through high-quality, safe, and diverse clinical research. The Regulatory Maintenance Specialist serves as the regulatory owner for the Bronx site, managing IRB submissions, study documentation, staff credentialing, sponsor and CRA action items, audit readiness, and study closeout activities.

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

Preferred

regulatory experience

Working knowledge of GCP and IRB processes

familiarity with FDA regulations and 21 CFR Part 11

Experience with eReg or eSource systems

CRIO a plus

Regulatory Experience

GCP

IRB Processes

FDA Regulations

21 CFR Part 11

eReg Systems

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

This is an onsite position with potential for a couple of work from home days.

Company

US clinical research sites for psychiatric and neurological trials

Watertown, Massachusetts, USA

https://www.adamsclinical.com/

Founded in 2011

201-500 employees

Qualifications

Bachelor's degree in life sciences, clinical research, or a related field

1-2 years of clinical trial experience

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

Regulatory experience

Working knowledge of GCP and IRB processes

Familiarity with FDA regulations and 21 CFR Part 11

Experience with eReg or eSource systems

CRIO a plus

Required skills

Clinical Trial Experience, Regulatory Affairs, Clinical Practice (GCP), IRB Processes, FDA Regulations, 21 CFR Part 11, eReg Systems, eSource Systems

Preferred skills

regulatory experience, Working knowledge of GCP and IRB processes, familiarity with FDA regulations and 21 CFR Part 11, Experience with eReg or eSource systems, CRIO a plus

Experience

1-2 years