Site Regulatory Specialist

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

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary, seeks a Site Regulatory Specialist to manage and track regulatory documents and protocol training to maintain site compliance with FDA and GCP requirements. You will collaborate with the regulatory affairs team, site leadership, and principal investigators to prepare for audits and meet deadlines.

This role requires an Associate's degree or higher, knowledge of clinical research terminology, and experience in a customer-focused

Qualifications

• Associate's degree, preferably Bachelor's.
• Knowledge of medical and clinical research terminology.
• At least one 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.

Responsibilities

• Provide site-level regulatory support related to start-up and ongoing regulatory maintenance.
• Establish and maintain a document management system for regulatory files.
• Maintain updated physician credentials and other critical documentation.
• Meet with monitors and auditors to review regulatory binder.
• Track documents pending site regulatory signatures.
• Route and track completion of protocol training.
• Maintain FDA and GCP regulatory documentation for site, studies, sponsors and networks.
• Ensure regulatory documents comply with local SOPs.

Skills

Clinical research terminology

Customer service

Education

Associate'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.