Regulatory Affairs Coordinator

Sarah Cannon Research Institute; Nashville (TN); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

Sarah Cannon Research Institute seeks a Regulatory Coordinator in Nashville, TN. This role manages regulatory affairs compliance, documents, and site start-up support across networks.

You'll ensure FDA/GCP documentation is current and aligned with SOPs, coordinating with investigators and operations teams. The successful candidate will have an associate degree (bachelor preferred) and regulatory or customer service experience.

Qualifications

• Associate degree or higher required; bachelor’s preferred.
• Regulatory experience is preferred.
• Customer service experience is preferred.

Responsabilités

• Manage regulatory affairs compliance for sponsors/sites and ensure deadlines are met.
• Process regulatory document signatures and maintain electronic signatures and file systems.
• Maintain FDA and GCP documentation for sites, studies, sponsors and networks.
• Triage site regulatory support requests and establish correct pathways for issue resolution.

Connaissances

Regulatory experience

Customer service experience

Associate degree

Formation

Associate Degree, preferably a Bachelor’s Degree

Description du poste

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. You will process regulatory document signature request through an electronic signature platform. You will track documents pending site regulatory signatures. You will provide 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. You will establish and maintain a document management system for regulatory paper and electronic files. 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 maintain updated physician credentials for network participants and other critical documentation ensuring compliance. You will triage site requests for regulatory support and identify correct pathway for issue resolution.

You should have for this position:

• 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.

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. 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.

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.