Site Regulatory Specialist

McKesson; Denver (CO); On-site; USD 37,000 - 47,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) seeks a Site Regulatory Specialist to manage regulatory documents and protocol training to ensure GCP and FDA compliance for industry-sponsored trials.

You will collaborate with regulatory affairs, site leadership and investigators to prepare for audits, maintain regulatory binders and credentialing, and route protocol training. A minimum Associate’s degree and 1 year in a customer-focused role are required; 3+ years in clinical research preferred.

Qualifications

• Associate’s Degree or higher; knowledge of medical/clinical terminology.
• At least 1 year in a customer-focused position.
• 3+ years of clinical research experience preferred.
• SOCRA or ACRP certification preferred.

Responsibilities

• Manage and track regulatory documents and protocol training to maintain site compliance with GCP and FDA requirements.
• Collaborate with regulatory affairs, site leadership and principal investigators to ensure compliance and auditing readiness.
• Establish and maintain a document management system for regulatory files; keep physician credentials up to date.

Skills

Regulatory knowledge

Customer focus

Attention to detail

Communication skills

Education

Associate’s Degree, preferably Bachelor’s Degree

Tools

SOCRA certification

ACRP certification

Job description

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 $27.00/hr - $34.00/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 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.

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. McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.