Clinical Regulatory Specialist: Multi-Site Trials

Pinnacle Clinical Research- A Summit Solution; Springfield (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Pinnacle Clinical Research- A Summit Solution in New Jersey seeks a Regulatory Associate to ensure timely preparation and submission of regulatory and IRB documents for multiple studies. You will coordinate with Investigators, Clinical Operations, Sponsors, CROs, IRBs, and staff to ensure adherence to GCP, ICH guidelines, HIPAA, sponsor requirements, and company SOPs.

This role provides regulatory support for approximately 45 trials across sites, maintains regulatory binders and training

Qualifications

• Bachelor degree in a scientific or health-related field or 3–4 years 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, especially Word and Excel, and with EDC/CRF systems.
• Strong organizational, written, and verbal communication skills with high attention to detail.
• Ability to manage multiple studies, priorities, and deadlines.
• Ability to collaborate with investigators, sponsors, CROs, IRBs, and internal teams.
• Ability to read and interpret delegation log templates, protocols, and procedures; drafting NTF documents.

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.
• Prepare for and assist with monitoring visits, audits, and inspections.
• Maintain HIPAA confidentiality and regulatory documentation discipline.

Skills

FDA regulations

ICH/GCP

HIPAA

IRB submissions

Regulatory docs

MS Word

MS Excel

EDC/CRF systems

Project management

Communication skills

Education

Bachelor's degree

Clinical research experience

Tools

IRB systems

CRIO/Clinical IO

Microsoft Office

Job description

Pinnacle Clinical Research- A Summit Solution in New Jersey seeks a Regulatory Associate to ensure timely preparation and submission of regulatory and IRB documents for multiple studies. You will coordinate with Investigators, Clinical Operations, Sponsors, CROs, IRBs, and staff to ensure adherence to GCP, ICH guidelines, HIPAA, sponsor requirements, and company SOPs.

This role provides regulatory support for approximately 45 trials across sites, maintains regulatory binders and training