Regulatory Lead for Clinical Trials

Pinnacle Clinical Research; Springfield (NJ); On-site; USD 65,000 - 95,000; Full time

Job summary

Pinnacle Clinical Research seeks a Regulatory Associate to support regulatory documentation and IRB submissions across multiple trials. You will coordinate initial and ongoing regulatory filings, maintain source documents, and ensure HIPAA and GCP compliance while liaising with investigators, sponsors, CROs, and IRBs.

Responsibilities include tracking submissions, coordinating amendments, and ensuring timely responses.

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

• Review study protocols, informed consent documents, responses to stipulations, and other study-related documentation to ensure conformance with all applicable requirements.
• Prepare, populate, and coordinate the initial submission of regulatory documents to the IRB, sponsors, and state or federal regulatory offices as necessary.
• Compile study information and prepare and submit initial, continuing, and final reports to the IRB and/or sponsor.
• Prepare applicable submission forms and submit updated documents, including amendments, addendums, investigator brochures, safety information, Form FDA 1572s, and informed consent documents.
• Track submissions, approvals, stipulations, and outstanding items; coordinate responses to sponsor, CRO, and IRB requests.
• Manage and update employee CVs and ensure copies of all current and applicable medical licenses and training documentation are on file.
• Create error-free written documents and reports, such as cover letters, notes-to-file, and memos.

Skills

FDA regulations

IRB submissions

GCP

HIPAA

EDC/CRF

Communication

Multitasking

Education

Bachelor's degree

Clinical research experience (3-4 years)

Tools

Microsoft Office

EDC/CRF systems

Job description

Pinnacle Clinical Research seeks a Regulatory Associate to support regulatory documentation and IRB submissions across multiple trials. You will coordinate initial and ongoing regulatory filings, maintain source documents, and ensure HIPAA and GCP compliance while liaising with investigators, sponsors, CROs, and IRBs.

Responsibilities include tracking submissions, coordinating amendments, and ensuring timely responses.