Clinical Regulatory Specialist

Pinnacle Clinical Research- A Summit Solution; Bellaire (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Pinnacle Clinical Research- A Summit Solution is seeking a Regulatory Associate to support regulatory submissions and IRB management across studies. You will prepare and maintain regulatory documents, track submissions, and coordinate with Investigators, Sponsors, CROs, and IRBs to ensure compliance with GCP, ICH, HIPAA, and SOPs.

The role requires a bachelor's degree or equivalent clinical research experience, strong documentation skills, and the ability to handle multiple trials and deadlines

Qualifications

• Bachelors degree or 3–4 years of 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 Word/Excel and web-based EDC/CRF systems.
• Strong organizational, written, and verbal communication with attention to detail.
• Ability to manage multiple studies and deadlines with diplomacy.

Responsibilities

• Review protocols, informed consent documents, and stipulations for compliance.
• Prepare, populate, and coordinate regulatory submissions to IRB, sponsors, and regulators.
• Compile study information and submit reports to IRB and sponsor.
• Track submissions, approvals, stipulations, and outstanding items; respond to requests.
• Manage employee CVs and ensure licenses and training docs are up to date.
• Create error-free reports, cover letters, and memos.
• Assist with monitoring visits, audits, and inspections.
• Maintain regulatory binders and electronic systems with version control.

Skills

FDA regulations

IRB submissions

GCP/ICH guidelines

HIPAA

Document control

Multitasking

Communication

Education

Bachelor's degree in science/health

Tools

EDC/CRF systems

Microsoft Office

Regulatory databases

CRIO

Job description

Pinnacle Clinical Research- A Summit Solution is seeking a Regulatory Associate to support regulatory submissions and IRB management across studies. You will prepare and maintain regulatory documents, track submissions, and coordinate with Investigators, Sponsors, CROs, and IRBs to ensure compliance with GCP, ICH, HIPAA, and SOPs.

The role requires a bachelor's degree or equivalent clinical research experience, strong documentation skills, and the ability to handle multiple trials and deadlines