Clinical Regulatory Associate — IRB & Submissions Expert

ADP, Inc.; Bellaire (TX); On-site; USD 55,000 - 75,000; Full time

Job summary

Automatic Data Processing, Inc. in Bellaire, TX, is seeking a Regulatory Associate to support regulatory and IRB documentation for multiple clinical trials.

You will coordinate submissions, manage regulatory binders, and ensure compliance with GCP, ICH, HIPAA, and sponsor requirements across sites. The role involves collaboration with investigators, sponsors, CROs, IRBs, and internal teams to maintain study timelines and confidentiality, under limited supervision.

Qualifications

• Bachelor's degree in a scientific, health-related, or relevant field or 3-4 years of equivalent clinical research experience.
• Working knowledge of FDA regulations, 21 CFR, ICH/GCP, HIPAA, and IRB requirements.
• Experience with clinical trial and/or regulatory documentation.
• Proficiency with Microsoft Office, particularly Word and Excel, and with web-based enterprise solutions and electronic case report form (EDC/CRF) systems.
• Strong organizational, written, and verbal communication skills with exceptional attention to detail.
• Ability to manage multiple studies, priorities, and time-sensitive deadlines, and to adapt to changing priorities.
• Ability to collaborate effectively with investigators, research staff, sponsors, CROs, IRBs, and internal departments in a diplomatic and professional manner.
• Ability to read and interpret documents such as delegation log templates, protocols, procedure manuals.
• Ability to write routine reports and correspondence, and draft NTF documents.
• Completion of required GCP training.

Responsibilities

• Coordinate regulatory submissions to IRBs, sponsors, and regulatory offices.
• Prepare and maintain regulatory documents and logs across the study lifecycle.
• Track submissions, approvals, stipulations, and outstanding items.
• Maintain regulatory binders and electronic systems with version control.
• Assist with monitoring visits, audits, and inspections.
• Support site activation and study initiation activities.
• Communicate with sponsors, CROs, IRBs, investigators, and research staff.

Skills

Regulatory knowledge

FDA/ICH/GCP familiarity

Documentation skills

Regulatory submissions

Communication skills

Education

Bachelor's degree in a scientific/health-related field

Tools

MS Office (Word, Excel)

Regulatory documentation systems

EDC/CRF familiarity

Job description

Automatic Data Processing, Inc. in Bellaire, TX, is seeking a Regulatory Associate to support regulatory and IRB documentation for multiple clinical trials.

You will coordinate submissions, manage regulatory binders, and ensure compliance with GCP, ICH, HIPAA, and sponsor requirements across sites. The role involves collaboration with investigators, sponsors, CROs, IRBs, and internal teams to maintain study timelines and confidentiality, under limited supervision.