Site Regulatory Specialist - Remote US

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.

This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Duties include and are not limited to:

• 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

Qualifications for success include:

• 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

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

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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.