Job description
The Opportunity:
REGENXBIO is an exceptional place where some of the best of brightest people have the opportunity to collaborate, touch amazing science, and contribute toward extraordinary plans. As a Contract Clinical Trial Trainer, you will assist in delivering clinical trial related curriculum modules, administration frameworks, training plans, and tracking mechanisms required to demonstrate adequate clinical trial training in line with ICH/GCP guidelines and all applicable Federal Regulations. You’ll also assist with clinical trial related Learning Management System (LMS) monitoring of clinical trial training compliance via the production and distribution of regular reports.This is a 6-month contract position with the potential to convert to permanent.
What you’ll be doing:
- 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.
What we’re looking for:
- Bachelor’s degree required with an emphasis on Life Sciences or equivalent.
- At least 2 years clinical trial and/or industry Standards/SOP/Quality training experience.
- 1-3 years’ data input experience with Learning Management Systems (Compliance Wire), additional experience using Veeva TMF preferred
- Must have working knowledge of ICH/GCP principals and demonstrate familiarity with industry standards.
- Ability to work in a dynamic, fast paced, team environment.
$0 - $1 a year
