Site Regulatory Specialist - Remote US

Sarah Cannon Research Institute•Nashville, TN

1d•Remote

About The Position

This is a remote position based in the US. The primary responsibilities include managing and tracking regulatory documents and protocol training to maintain site compliance for industry sponsors and GCP/FDA requirements. This position will work closely with the Regulatory Affairs department, site leadership and/or principal investigators to ensure compliance as well as preparing for auditing activities while meeting strict deadlines. Relocation assistance and visa sponsorship are not available.

Requirements

Associate's Degree, with Bachelor's Degree preferred
1 - 3 years' work experience in a clinical research, health care, hospital, or pharmaceutical environment
Experience with medical and clinical research terminology
Work experience with all MS Office Suite of products including Excel, Microsoft Word, PowerPoint, SharePoint, and Outlook
Experience working in an environment requiring good organizational skills and solid deadlines

Responsibilities

Provides site level regulatory support to the TN Oncology site and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
Establishes and maintains a document management system for regulatory paper and electronic files for each study at the site
Maintains updated physician credentials for TN Oncology site and other critical documentation ensuring compliance
Meet with monitors and auditors to review regulatory binder
Tracks documents pending site regulatory signatures
Posts and permissions protocol documents
Other duties as assigned