Posted:
7/29/2024, 5:00:00 PM
Location(s):
Nashville-Davidson, Tennessee, United States ⋅ Tennessee, United States
Experience Level(s):
Junior ⋅ Mid Level
Field(s):
Legal & Compliance
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.
This position is based on site in Nashville, TN.
As the Site Regulatory Specialist, you are responsible for managing and tracking regulatory documents and protocol training to maintain site compliance for industry sponsors and Food and Drug Administration (FDA) and Good Clinical Practice (GCP) requirements. You will work closely with the regulatory affairs department, site leadership and/or 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 SCRI site 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 papers and electronic files for each study at the site
You will maintain updated physician credentials for SCRI sites and other critical documentation ensuring compliance
You will meet with monitors and auditors to review regulatory binders
You will track documents pending site regulatory signatures
You will route and track completion of protocol training
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 triage site requests for regulatory support and identifies correct pathway for issue resolution
You should have for this position:
An Associate’s Degree, preferably a Bachelor’s Degree
Knowledge of medical and clinical research terminology
At least one year of customer service experience required
Clinical research experience preferred
Regulatory experience preferred
SOCRA certification or ACRP certification 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 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.
Website: https://macrohelix.com/
Headquarter Location: Atlanta, Georgia, United States
Employee Count: 101-250
Year Founded: 2009
IPO Status: Private
Industries: Information Technology ⋅ Software