Clinical Trials Regulatory Specialist II

US Oncology Inc.; Salem (VA); On-site; USD 32,000 - 48,000; Full time

Job summary

US Oncology Inc. is seeking a regulatory professional to oversee research regulatory and administrative activities for clinical trials in a fast-paced outpatient clinic setting.

You will ensure compliance with GCP, HIPAA, OSHA and applicable laws while coordinating with investigators and central offices. The role includes document management, training, protocol submissions, and QA initiatives to improve processes and study quality across the site.

Qualifications

• High School Diploma required; Associate's degree preferred.
• Minimum 3 years of experience in clinical research, regulatory affairs and/or oncology.
• Experience in working with Sponsor Monitor representatives.

Responsibilities

• Track and complete protocol feasibility questionnaires with investigators.
• Coordinate Critical Document Collection for timely trial openings.
• Communicate regulatory issues with central operations and data management.
• Maintain Protocol Regulatory Documents per SOPs and regulations.
• Coordinate audits and visits; report regulatory issues to staff/ investigators.
• Prepare Informed Consent Documents and regulatory packets (FDA1572, FDQ).
• Collect site training documents and participate in study initiations and trainings.

Skills

Regulatory expertise

Communication skills

Multi-tasking

Time management

Interpersonal skills

Attention to detail

Fast-paced environment

Education

High School Diploma

Associate's degree in clinical or scientific related discipline

Tools

Microsoft Office

Job description

US Oncology Inc. is seeking a regulatory professional to oversee research regulatory and administrative activities for clinical trials in a fast-paced outpatient clinic setting.

You will ensure compliance with GCP, HIPAA, OSHA and applicable laws while coordinating with investigators and central offices. The role includes document management, training, protocol submissions, and QA initiatives to improve processes and study quality across the site.