Remote Regulatory Affairs Manager: Oncology Trials

Sarah Cannon Research Institute; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization with a nationwide network of clinical trials. This remote role oversees the regulatory operations for site Clinical Operations, ensuring FDA/GCP compliance and audit readiness while aligning with strategic plans and cross-functional partners.

The Regulatory Affairs Manager will lead regulatory policies, manage sponsor relationships, and coordinate with primary investigators and industry sponsors to support trial

Qualifications

• Bachelor’s Degree required.
• 1+ year work experience with 5+ years’ preferred in clinical research corporation and regulatory team; education may substitute partially.
• Knowledge of scientific and clinical research terminology.
• Knowledge of FDA and GCP guidelines.
• Knowledge of organizational policies, procedures, and systems.
• Advanced skills with MS Office products including Excel, Word, Outlook.
• Experience meeting strict deadlines and supervising team members.

Responsibilities

• Manages regulatory department activities and schedules.
• Establishes and enforces procedures ensuring trial teams/sites comply with laws, regulations, SOPs, and guidelines.
• Develops and implements regulatory policies for site operations and Clinical Operations team.
• Manages regulatory affairs between the organization for multiple clinical trials according to FDA and GCP.
• Oversees regulatory audits by sponsors/industry and governmental auditors.
• Other duties as assigned.

Skills

Regulatory affairs

FDA guidelines

GCP guidelines

Team supervision

Clinical research terminology

Education

Bachelor's Degree

Tools

MS Office

Job description

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization with a nationwide network of clinical trials. This remote role oversees the regulatory operations for site Clinical Operations, ensuring FDA/GCP compliance and audit readiness while aligning with strategic plans and cross-functional partners.

The Regulatory Affairs Manager will lead regulatory policies, manage sponsor relationships, and coordinate with primary investigators and industry sponsors to support trial