Regulatory Affairs Coordinator

McKesson; Tennessee; Vor Ort; USD 60.000 - 75.000; Vollzeit

Zusammenfassung

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Regulatory Coordinator to manage regulatory affairs and ensure compliance for sponsors and sites. You will work with regulatory management, department directors, and investigators to meet deadlines and audits.

The role involves maintaining FDA/GCP documentation, implementing a document management system, and supporting site start-up and ongoing regulatory maintenance across networks.

Qualifikationen

• Associate Degree, preferably a Bachelor’s Degree.
• Regulatory experience preferred.
• Customer service experience preferred.

Aufgaben

• Process regulatory document signature requests via an electronic signature platform.
• Track documents pending site regulatory signatures.
• 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.
• Establish and maintain a document management system for regulatory paper and electronic files.
• Maintain FDA and Good Clinical Practice (GCP) regulatory documentation for individual sites, studies, sponsors and/or networks.
• Ensure all regulatory documentation is compliant with local SOPs for format and content.
• Maintain updated physician credentials for network participants and other critical documentation ensuring compliance.
• Triage site requests for regulatory support and identify correct pathway for issue resolution.

Kenntnisse

Regulatory experience

Customer service experience

Ausbildung

Associate Degree, preferably a Bachelor’s Degree

Jobbeschreibung

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 personalising treatment. Through clinical excellence and cutting‑edge research, SCRI is redefining cancer care around the world.

Regulatory Coordinator Overview

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

• Process regulatory document signature requests through an electronic signature platform.
• Track documents pending site regulatory signatures.
• 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.
• Establish and maintain a document management system for regulatory paper and electronic files.
• Maintain Food and Drug Administration (FDA) and Good Clinical Practice (GCP) required regulatory documentation for individual sites, studies, sponsors and/or other networks.
• Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.
• Maintain updated physician credentials for network participants and other critical documentation ensuring compliance.
• Triage site requests for regulatory support and identify correct pathway for issue resolution.

Qualifications

• 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.

Total Rewards & Benefits

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.

EEO Statement

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.

About McKesson

We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives.
Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight‑year‑old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare.

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