Regulatory Research Assistant - (Clinical Research)

CenExel•Riverside, CA

6d•$20 - $22•Hybrid

About The Position

Assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies in accordance to site SOPs, ICH, GCP, and FDA guidelines. This role involves ensuring compliance with current protocols, site SOPs, GCPs, IRB, and FDA guidelines. The assistant will be responsible for uploading regulatory documents using the RealTime eDOCs System, preparing, organizing, and maintaining regulatory and training documents, and tracking submissions for timely filing. The position also requires obtaining CVs and signatures for regulatory documents, forwarding revised study documents, assisting in obtaining investigator signatures, and working closely with study sponsors/CROs and clinical trial personnel on regulatory document issues. Ensuring Clinical Conductor regulatory information is current, participating in team meetings, and complying with training requirements are also key duties. The role supports adherence to best practices, FDA Code of Federal Regulations, ICH, GCP, CenExel SOPs, site working practices, protocols, and company guidelines. Additional duties may be assigned.

Requirements

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 is 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 Code of Federal Regulations, ICH, GCP, CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned.