Clinical Trials Regulatory Specialist

Automatic Data Processing, Inc.; Springfield (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Automatic Data Processing, Inc. in Springfield, NJ is seeking a Regulatory Associate to support clinical trials by preparing and submitting regulatory and IRB documentation across multiple studies.

You will work with Investigators, Sponsors, CROs, IRBs, and other stakeholders to ensure compliance with GCP, ICH, HIPAA, sponsor requirements, and company SOPs. The role emphasizes coordination of submissions, regulatory binders, and communication to keep study timelines on track, with strong

Qualifications

• Bachelor’s degree or 3-4 years clinical research experience.
• Knowledge of FDA regulations, 21 CFR, ICH/GCP, HIPAA.
• Experience with regulatory documentation.
• Proficiency with Word and Excel; familiarity with web-based EDC/CRF systems.
• Strong organizational and written/verbal communication skills.

Responsibilities

• Review regulatory documents for conformance with requirements.
• Prepare and coordinate initial regulatory submissions to IRBs and sponsors.
• Track submissions, approvals, and outstanding items; coordinate responses.
• Maintain regulatory binders and ensure licenses/training docs are up to date.
• Assist with audits, inspections, and archival of trial documents.

Skills

FDA regulations knowledge

Regulatory documentation

Communication skills

Organization skills

Education

Bachelor's degree

Clinical research experience

Tools

Microsoft Office

Excel

EDC/CRF systems

Job description

Automatic Data Processing, Inc. in Springfield, NJ is seeking a Regulatory Associate to support clinical trials by preparing and submitting regulatory and IRB documentation across multiple studies.

You will work with Investigators, Sponsors, CROs, IRBs, and other stakeholders to ensure compliance with GCP, ICH, HIPAA, sponsor requirements, and company SOPs. The role emphasizes coordination of submissions, regulatory binders, and communication to keep study timelines on track, with strong