Clinical Trials Regulatory Associate

Pinnacle Clinical Research; Bellaire (TX); On-site; USD 70,000 - 95,000; Full time

Job summary

Pinnacle Clinical Research in Bellaire, TX is seeking a Regulatory Associate to support regulatory and IRB documentation for multiple trials. You will coordinate submissions, maintain regulatory binders, and ensure compliance across sites.

The role requires strong knowledge of FDA regulations, ICH/GCP, HIPAA, and IRB requirements, plus proficiency with MS Office and EDC/CRF systems. Collaborative communication with sponsors and investigators is essential.

Qualifications

• Bachelor's degree 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 documentation.
• Proficiency with Word, Excel, and web-based enterprise solutions and EDC/CRF systems.
• Strong organizational, written, and verbal communication with attention to detail.
• Ability to manage multiple studies, priorities, and deadlines.
• Ability to collaborate with investigators, sponsors, CROs, IRBs, and internal departments.
• Ability to read/interpret delegation log templates, protocols, and manuals.
• Ability to write routine reports and draft NTF documents.
• Completion of required GCP training.

Responsibilities

• Regulatory Submissions and IRB Management
• Regulatory Documentation and Compliance
• Study Support and Communication
• Perform other duties as assigned.

Skills

Regulatory knowledge

Documentation proficiency

Communication skills

Project management

Education

Bachelor's degree in science/health or related field

3–4 years clinical research experience

Tools

Microsoft Word

Microsoft Excel

EDC/CRF systems

Job description

Pinnacle Clinical Research in Bellaire, TX is seeking a Regulatory Associate to support regulatory and IRB documentation for multiple trials. You will coordinate submissions, maintain regulatory binders, and ensure compliance across sites.

The role requires strong knowledge of FDA regulations, ICH/GCP, HIPAA, and IRB requirements, plus proficiency with MS Office and EDC/CRF systems. Collaborative communication with sponsors and investigators is essential.