Site Regulatory Specialist

Sarah Cannon Research Institute•Denver, CO

10d

About The Position

As the Site Regulatory Specialist you will manage and track regulatory documents and protocol training to maintain site compliance for industry sponsors and Good Clinical Practice (GCP) and Food and Drug Administration (FDA) requirements. You will work closely with the regulatory affairs department, site leadership and principle investigators to ensure compliance as well as preparing for auditing activities while meeting strict deadlines. You will provide site level regulatory support to the research site in relation to the status of start-up and ongoing regulatory maintenance.

Requirements

An Associate’s Degree, preferably a Bachelor’s Degree
Knowledge of medical and clinical research terminology
At least one year of experience in a customer focused position

Nice To Haves

At least three years of clinical research experience preferred
At least three years of regulatory experience preferred
SOCRA certification preferred
ACRP certification preferred

Responsibilities

Establish and maintain a document management system for regulatory paper and electronic files for each study at the site
Maintain updated physician credentials and other critical documentation ensuring compliance
Meet with monitors and auditors to review regulatory binder
Track documents pending site regulatory signatures
Route and track completion of protocol training
Maintain FDA and GCP required regulatory documentation for individual site, studies, sponsors and/or other networks.
Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
Triage site requests for regulatory support and identify correct pathway for issue resolution
Maintain organization of Regulatory File room, including archiving notebooks as needed