Research Regulatory Affairs Specialist

Sarah Cannon Research Institute; Tennessee; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Total Rewards benefits

Competitive compensation

Job summary

Sarah Cannon Research Institute (SCRI) is seeking a Research Regulatory Affairs Specialist to manage regulatory compliance for industry sponsors and sites within networks. You will work with regulatory affairs management, department director, and investigators to ensure timely audits and maintain a full study workload with minimal supervision.

The role requires knowledge of FDA, GCP, and regulatory processes, with an emphasis on documentation, IRB submissions, and HIPAA considerations.

Qualifications

• Associate degree or higher preferred; high school diploma required; qualifying experience may substitute education.

Responsibilities

• Establishes and maintains a document management system for regulatory electronic files.
• Maintains FDA and GCP required regulatory documentation for sites, studies, sponsors and networks.
• Maintains critical documentation ensuring compliance.
• Modifies and updates informed consent forms and manages protocol, investigator drug brochure, and consent form changes per IRB/HIPAA.
• Organizes IRB submissions for multiple trials.
• Processes Protocol Deviations that meet IRB reportable criteria.
• Submits urgent safety notifications to the IRB.
• Other duties as assigned.

Skills

Regulatory affairs

Clinical research

FDA regulatory processes

Education

Associate's degree or higher preferred

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.

Research Regulatory Affairs Specialist

Primary responsibilities include managing and planning regulatory affairs compliance for industry sponsors and/or sites in networks. This position 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. The Regulatory Affairs Specialist I will maintain a full study workload with minimal supervision.

Duties include and are not limited to:

• Establishes and maintains a document management system for regulatory electronic files
• Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOPs) for format and content
• Maintains critical documentation ensuring compliance
• Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA. This includes time sensitive correspondence with sponsors and other stakeholders.
• Organizes and processes documentation for IRB submission for multiple trials
• Processing of Protocol Deviations that meet the IRB reportable criteria
• Submits urgent safety notifications to the IRB
• Other duties as assigned

Qualifications for success include:

• Associate's Degree or higher is preferred, high school graduation diploma required - qualified experience may be substituted for education
• 1+ year work experience in a clinical research, pharmaceutical, site management organization highly desired focused in required regulatory affairs
• Knowledge of medical terminology, FDA, other regulatory processes highly 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. 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.