Site Regulatory Specialist

Sarah Cannon Research Institute•Nashville, TN

21d

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. We are adding a Site Regulatory Specialist to our team! 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.

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 SCRI Oncology Partners 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 SCRI OP 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