Regulatory Research Assistant, Clinical Trials Support

Cenexelresearch; Riverside, Northern (CA, KY); Hybrid; USD 28,000 - 30,000; Full time

Benefits offered by this job

Health Insurance

Dental

Vision

401k

Job summary

CenExel Clinical Research in Riverside, CA is seeking a Regulatory Research Assistant to support regulatory document management for clinical trials. The role focuses on maintaining compliance with SOPs, ICH, GCP, and FDA guidelines, and preparing essential regulatory submissions.

The position requires at least 1 year of clinical research experience, strong communication skills, and the ability to work under minimal supervision in a fast-paced environment.

Qualifications

• Must communicate effectively in writing and verbally.
• High School graduate or equivalent.
• Minimum 1 year of related experience in clinical research.
• Self-directed and able to work with minimal supervision.

Responsibilities

• Complies with current protocols, SOPs, GCPs, IRB and FDA guidelines.
• Uploads regulatory documents using RealTime eDOCs System; maintains paper binders as needed.
• Prepares and maintains regulatory and training documents.
• Tracks submissions to ensure timely filing of documents.
• Obtains CVs of external investigators and signatures for regulatory documents.
• Assists in obtaining required signatures from investigators.
• Coordinates with sponsors/CRO and clinical trial personnel on regulatory issues.
• Ensures regulatory information is current in CenExel systems.
• Participates in team meetings and trainings.
• Supports sponsors/CROs as needed.

Skills

Communication skills

Self-direction

Prioritization

Adaptability

Education

High School diploma

Tools

RealTime eDOCs System

Job description

CenExel Clinical Research in Riverside, CA is seeking a Regulatory Research Assistant to support regulatory document management for clinical trials. The role focuses on maintaining compliance with SOPs, ICH, GCP, and FDA guidelines, and preparing essential regulatory submissions.

The position requires at least 1 year of clinical research experience, strong communication skills, and the ability to work under minimal supervision in a fast-paced environment.