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REGENXBIO · 3 months ago

Contract Clinical Trial Trainer

United States

Contract

Remote

Entry, Mid Level

$0/yr - $1/yr

2+ years exp

REGENXBIO is an exceptional place where some of the best and brightest people have the opportunity to collaborate and contribute toward extraordinary plans. As a Contract Clinical Trial Trainer, you will assist in delivering clinical trial related curriculum modules and training plans, ensuring compliance with ICH/GCP guidelines and Federal Regulations. You will also support the monitoring of clinical trial training compliance through the Learning Management System.

BiopharmaBiotechnologyGeneticsTherapeutics

Responsibilities

Assist in the development of clinical trial training programs, including curriculums, training plans, guidances, etc. required to demonstrate adequate clinical trial training in line with ICH/GCP guidelines and Federal Regulations

Coordinate, administer and archive documentation for clinical trial training courses (presentations, recordings, and/or instructor led classes)

Support management with oversight of clinical trial training calendar and risk tool maintaining adherence with REGENXBIO standard operating procedures and guidelines

Liaise with the Sr. Manager Clinical Trial Training and other Business Operations/Quality Assurance leads to assess/communicate clinical trial training compliance, identify gaps, and implement corrective/preventive actions where needed

Assist in the onboarding of Medical Organization new study members with training assignments, standard training processes, tools, and best practices as needed

Support updates to REGENXBIO Learning Management System (LMS) curriculums, including update to study specific/core curriculums, tracking capabilities, and all associated compliance reports as needed