Oncology Clinical Trials Regulatory Coordinator II

US Oncology Network-wide Career Opportunities; Salem (VA); On-site; USD 32,000 - 49,000; Full time

Job summary

US Oncology Research, Inc. (USOR) seeks a Regulatory Specialist to oversee research regulatory and administrative activities for clinical trials. This role supports SOPs, GCP, and applicable regulations, coordinating site qualification and regulatory document management to ensure quality.

You will train staff, collaborate on process improvements, and ensure timely regulatory submissions and QA initiatives across trial sites, in a fast-paced outpatient environment.

Qualifications

• High School Diploma required; an Associate's degree in a clinical or scientific-related discipline is preferred.
• Minimum 3 years of experience in clinical research, regulatory affairs and/or an oncology-related field is required.

Responsibilities

• Track and complete protocol feasibility questionnaires; coordinate critical document collection to facilitate timely opening of trials.
• Maintain Protocol Regulatory Documents in compliance with SOPs.
• Coordinate scheduling and setup for audits and monitor, start-up, and close-out visits; communicate regulatory issues to staff.
• Prepare Informed Consent Documents and regulatory packets (FDA1572, FDQ) for sponsor and IRB submissions; coordinate IRB submissions.
• Facilitate collection of site training documents and participate in study initiations and educational programs; monitor information for continuing review by IRB or Network PI.
• Provide SME guidance; orient/train other staff in regulatory processes.
• Collaborate with research staff and management on process improvement and QA initiatives.

Skills

communication skills

multitasking

time management

interpersonal skills

attention to detail

fast-paced environment

Microsoft Office

sponsor monitors

Education

High School Diploma

Associate's degree in clinical or scientific field preferred

Tools

Microsoft Office

Job description

US Oncology Research, Inc. (USOR) seeks a Regulatory Specialist to oversee research regulatory and administrative activities for clinical trials. This role supports SOPs, GCP, and applicable regulations, coordinating site qualification and regulatory document management to ensure quality.

You will train staff, collaborate on process improvements, and ensure timely regulatory submissions and QA initiatives across trial sites, in a fast-paced outpatient environment.