Regulatory Research Assistant (Remote-Friendly)

CenExel; Riverside (CA); On-site; USD 42,000 - 46,000; Full time

Benefits offered by this job

Health Insurance

Dental

Vision

LTD

STD

Life Insurance

401k

Job summary

CenExel Clinical Research is seeking a Regulatory Documents Coordinator to assist the Regulatory Specialists/Manager in maintaining clinical trial documents for regulatory submissions in line with site SOPs, ICH, GCP, and FDA guidelines.

The role supports RealTime eDOCs document uploads, manages CVs for investigators and staff, and ensures timely filing and current regulatory information. Monday–Friday, with flexibility in travel as needed.

Qualifications

• Must be able to effectively communicate verbally and in writing.
• Minimum: High School graduate or equivalent.
• Minimum of 1 year of related experience in clinical research.
• Must be self-directed and able to work with minimal supervision.
• Able to take a flexible approach to shifting priorities.
• Motivated to work consistently in a fast-paced and rapidly changing environment.

Responsibilities

• Complies with current protocols, site SOPs, GCPs, IRB and FDA guidelines.
• Uploads regulatory documents with RealTime eDOCs System and files in paper binders, as necessary.
• Prepares, obtains, organizes and maintains regulatory and training documents in various storage mediums.
• Tracks submissions and ensure timely filing of documents.
• Obtains CVs of external Investigators and other contract personnel and their signatures for appropriate regulatory documents.
• Forwards revised copies of protocols, informed consents, and other pertinent study documents to appropriate staff.
• Assists in obtaining necessary signatures from investigators.
• Works closely with study sponsor/CRO and key clinical trial personnel on relevant regulatory document issues.
• Ensures Clinical Conductor regulatory information is current.
• Participates in team meetings and complies with training requirements.
• Assists sponsors/CRO’s as needed.
• Supports and ensures strictest adherence to best practices, FDA CFR, ICH, GCP, CenExel SOPs, site working practices, protocol, and company guidelines and policies.

Skills

Verbal communication

Written communication

Self-directed

Adaptable priorities

Fast-paced environment

Education

High School diploma or equivalent

Job description

CenExel Clinical Research is seeking a Regulatory Documents Coordinator to assist the Regulatory Specialists/Manager in maintaining clinical trial documents for regulatory submissions in line with site SOPs, ICH, GCP, and FDA guidelines.

The role supports RealTime eDOCs document uploads, manages CVs for investigators and staff, and ensures timely filing and current regulatory information. Monday–Friday, with flexibility in travel as needed.