Site Regulatory Specialist

McKesson Corporation
United States, Colorado, Denver
5301 Peoria St Unit E (Show on map)
Dec 23, 2024
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 Site Regulatory Specialist you will manage and track regulatory documents and protocol training to maintain site compliance for industry sponsors and Good Clinical Practice (GCP) and Food and Drug Administration (FDA) requirements. You will work closely with the regulatory affairs department, site leadership and 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 research site 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 for each study at the site You will maintain updated physician credentials and other critical documentation ensuring compliance You will meet with monitors and auditors to review regulatory binder You will track documents pending site regulatory signatures You will route and track completion of protocol training You will maintain FDA and GCP required regulatory documentation for individual site, 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 identify correct pathway for issue resolution You will maintain organization of Regulatory File room, including archiving notebooks as needed You will need for this position An Associate's Degree, preferably a Bachelor's Degree Knowledge of medical and clinical research terminology At least on year of experience in a customer focused position At least three years of clinical research experience preferred At least three years of regulatory experience preferred SOCRA certification preferred ACRP certification preferred Expected pay $24.57/hr - $28.00/hr 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 750 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 today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 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. 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.