Clinical Research Safety Specialist - Remote US

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is a globally recognized leader in community-based oncology research. SCRI's mission is to improve cancer patient outcomes through innovative clinical trials and personalized treatments. With a network of over 1,300 physicians across more than 200 sites in 20+ states, SCRI has been instrumental in advancing cancer care and facilitating the approval of numerous new therapies.

Role Overview

The Clinical Research Safety Specialist is vital in promoting regulatory compliance and ensuring participant safety throughout clinical study processes. This position primarily manages submissions to Institutional Review Boards (IRBs), maintenance of essential regulatory documentation such as IND Safety Reports and Investigator Brochures, and supports oversight activities to meet regulatory standards across the lifecycle of clinical trials. This role further assists with regulatory affairs for both industry-sponsored and investigator-initiated research.

Primary Duties

• Prepare and submit all required documentation to institutional oversight entities including IRBs.
• Maintain complete and organized records of IND Safety Reports, Investigator Brochures, and other critical regulatory materials.
• Oversee adherence to FDA, IRB, and Good Clinical Practice (GCP) guidelines, as well as sponsor and institutional policies.
• Support ongoing regulatory submissions and activities within clinical trials sponsored by industry and investigator-initiated studies.
• Liaise closely with Regulatory Affairs leadership, study teams, and Principal Investigators to facilitate efficient regulatory processes.
• Ensure regulatory filings are audit-ready for internal and external review.
• Manage multiple priorities and deadlines, ensuring timely and accurate completion of compliance tasks.
• Carry out additional tasks as assigned within regulatory and safety domains.

Required Qualifications and Skills

• Bachelor's degree is mandatory.
• At least one year of professional experience in clinical research, biotechnology, life sciences, pharmaceutical, or hospital settings.
• Proficient understanding of Institutional Review Board (IRB) protocols, FDA regulations, and Good Clinical Practice (GCP) standards.
• Familiarity with scientific and clinical research terminology.
• Advanced proficiency in Microsoft Office suite, particularly Word, Excel, and Outlook.
• Outstanding organizational capabilities and meticulous attention to detail.

Additional Information

This role is fully remote within the United States. Candidates must be eligible to work in the US without relocation assistance or visa sponsorship. The employer provides a competitive total rewards package, including benefits supporting physical, mental, and financial wellness. Compensation is based on performance, experience, skill level, and location, and may include bonuses or long-term incentives. Candidates should remain vigilant against recruitment scams, as noted by McKesson.