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CenExel · 1 month ago

Regulatory Assistant - Clinical Research

Anaheim, CA

Full-time

Hybrid

Entry Level

$20/hr - $22/hr

1+ years exp

CenExel is a company specializing in Phase I to Phase IV clinical trials with a focus on quality and teamwork. The Regulatory Assistant will assist the Regulatory Specialists/Manager in maintaining clinical trial documents for submission to regulatory agencies, ensuring compliance with various guidelines and protocols.

Clinical TrialsHealth CarePharmaceutical

Responsibilities

Complies with current protocols, site SOPs, GCPs, IRB (Institutional Review Board) 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 (Curriculum Vitae) 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 (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies

Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive