Regulatory Affairs Specialist

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is a leading community-based cancer research organization committed to advancing oncology treatments and improving outcomes worldwide. With a network of over 1,300 physicians and more than 200 sites across 20+ states, SCRI has conducted over 850 first-in-human clinical trials and contributed to many FDA-approved cancer therapies. Our mission centers on supporting people affected by cancer by combining cutting-edge research with compassionate care.

Job Overview

The Clinical Regulatory Affairs Specialist will manage regulatory compliance for industry sponsors and clinical sites within networks. This fully remote, full-time position based in the United States requires working closely with regulatory management, department directors, and investigators to ensure all regulatory documentation meets FDA, GCP, and institutional standards. The specialist will also prepare for audits and handle a full caseload independently.

Key Responsibilities

• Develop and maintain an electronic document management system for regulatory files.
• Ensure all regulatory documentation for sites, studies, sponsors, and networks adheres to FDA, GCP, and local SOP requirements.
• Manage and update critical regulatory documents to maintain compliance.
• Revise and create informed consent forms; update protocols, investigator brochures, and consent amendments per IRB and HIPAA policies.
• Coordinate IRB submissions across multiple trials.
• Handle processing of protocol deviations reportable to IRB.
• Submit urgent safety notifications to the IRB promptly.
• Perform additional tasks as assigned.

Qualifications

• High school diploma required; associate degree or higher preferred. Relevant experience may substitute for education.
• Minimum one year of experience in clinical research, pharmaceutical industry, or site management with emphasis on regulatory affairs preferred.
• Familiarity with medical terminology, FDA regulations, and regulatory processes is highly desirable.

Compensation & Benefits

A competitive remuneration package is offered, influenced by factors such as experience, performance, and geographic location. Benefits aim to support employees’ physical, mental, and financial well-being as part of a comprehensive Total Rewards program.

Additional Information

This role does not offer relocation assistance or visa sponsorship. McKesson, the parent company, is vigilant against recruitment scams; legitimate communications come only through official channels and never solicit payment or sensitive information. The organization is an equal opportunity employer, valuing diversity and fostering an inclusive work environment.