Oncology Site Regulatory Specialist

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

Job summary

Sarah Cannon Research Institute (SCRI) seeks a Site Regulatory Specialist to manage regulatory documents and protocol training to ensure GCP and FDA compliance for industry-sponsored trials.

You will collaborate with regulatory affairs, site leadership and investigators to prepare for audits, maintain regulatory binders and credentialing, and route protocol training. A minimum Associate’s degree and 1 year in a customer-focused role are required; 3+ years in clinical research preferred.

Qualifications

• Associate’s Degree or higher; knowledge of medical/clinical terminology.
• At least 1 year in a customer-focused position.
• 3+ years of clinical research experience preferred.
• SOCRA or ACRP certification preferred.

Responsibilities

• Manage and track regulatory documents and protocol training to maintain site compliance with GCP and FDA requirements.
• Collaborate with regulatory affairs, site leadership and principal investigators to ensure compliance and auditing readiness.
• Establish and maintain a document management system for regulatory files; keep physician credentials up to date.

Skills

Regulatory knowledge

Customer focus

Attention to detail

Communication skills

Education

Associate’s Degree, preferably Bachelor’s Degree

Tools

SOCRA certification

ACRP certification

Job description

Sarah Cannon Research Institute (SCRI) seeks a Site Regulatory Specialist to manage regulatory documents and protocol training to ensure GCP and FDA compliance for industry-sponsored trials.

You will collaborate with regulatory affairs, site leadership and investigators to prepare for audits, maintain regulatory binders and credentialing, and route protocol training. A minimum Associate’s degree and 1 year in a customer-focused role are required; 3+ years in clinical research preferred.