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.

As the Regulatory Site Specialist you are responsible for managing and tracking regulatory documents and protocol training to maintain site compliance for industry sponsors and Food and Drug Administration (FDA) and Good Clinical Practice (GCP) requirements. You will work closely with the regulatory affairs department, site leadership and/or 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 Tennessee Oncology site and internal department managers in relation to the status of start-up and ongoing regulatory maintenance

• You will establish and maintain a document management system for regulatory papers and electronic files for each study at the site

• You will maintain updated physician credentials for Tennessee Oncology sites and other critical documentation ensuring compliance

• You will meet with monitors and auditors to review regulatory binders

• You will track documents pending site regulatory signatures

• You will route and track completion of protocol training

• You will maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. You will ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content

• You will triage site requests for regulatory support and identifies correct pathway for issue resolution

You should have for this position:

• An Associate’s Degree, preferably a Bachelor’s Degree

• Knowledge of medical and clinical research terminology

• At least one year of customer service experience required

• Clinical research experience preferred

• Regulatory experience preferred

• SOCRA certification or ACRP certification preferred

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.