Regulatory Affairs Coordinator

Regulatory Coordinator

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 Coordinator you are responsible for managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. In this position you will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, preparing for auditing activities while meeting strict deadlines.

Responsibilities include:

• Processing regulatory document signature requests through an electronic signature platform
• Tracking documents pending site regulatory signatures
• Providing site level regulatory support to the Clinical Operations' sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
• Establishing and maintaining a document management system for regulatory paper and electronic files
• Maintaining Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensuring all regulatory documentation is compliant with local Standard Operating Procedures (SOP's) for format and content
• Maintaining updated physician credentials for network participants and other critical documentation ensuring compliance
• Triaging site requests for regulatory support and identifies correct pathway for issue resolution

Qualifications include:

• An Associate Degree, preferably a Bachelor's Degree
• Regulatory experience is preferred
• Customer service experience is preferred

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.

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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.