Oncology Clinical Trials Regulatory Coordinator

Tennessee Oncology; Nashville (TN); On-site; USD 60,000 - 80,000; Full time

Job summary

Tennessee Oncology is seeking a Research Regulatory Coordinator to provide regulatory oversight for a network of oncology clinical trials from start-up to close-out. You will manage regulatory documents, submissions, approvals, amendments, and safety reporting while ensuring compliance with FDA, IRB, and institutional requirements across multiple protocols and phases.

As a liaison between investigators, sponsors, and regulatory bodies, you will drive timelines, inspection readiness, and

Qualifications

• Bachelor’s Degree in a health, life science, or related field required; or a minimum of 6 years of experience in clinical research, healthcare administration or regulatory field.
• Minimum of 2+ years of experience in clinical research required; OR 1 year of clinical research experience plus 1 year of healthcare administration or regulatory experience required.
• GCP certification within 30 days of hire if not already available.

Responsibilities

• Establishes and maintains comprehensive regulatory files for assigned studies.
• Ensures all regulatory documentation is organized, inspection-ready, and maintained per sponsor, institutional, and regulatory requirements.
• Prepares and submits regulatory documents to sponsors/CROs, including FDA Form 1572, CVs, licenses, disclosures, training records.
• Reviews and signs on study protocols, amendments, ICBs, and informed consent forms within timelines.
• Maintains Financial Disclosure Forms for investigators and staff.
• Creates and maintains Delegation of Authority Logs, FDA Form 1572s, Site Signature Logs.
• Coordinates IRB submissions for initial approvals, amendments, continuing reviews, and more.
• Tracks IRB deadlines, credential renewals, and training expirations.
• Reviews IND Safety Reports, SUSARs, safety letters, and interim safety communications.
• Supports audits by maintaining audit-ready regulatory files and responding to queries.
• Coordinates SAE submissions and regulatory reporting to IRBs and sponsors.
• Maintains training and study-related education records for staff.
• Documents protocol updates and regulatory changes to investigators and staff.
• Assists with internal quality reviews, sponsor audits, and CAPA tracking.
• Collaborates with investigators, sponsors, CROs, IRBs, and departments to enable study activation and close-out.
• Keeps knowledge current on FDA regs, ICH-GCP, HIPAA, and policies.

Skills

Regulatory knowledge

GCP certification

Analytical skills

Organizational skills

Communication skills

Microsoft Office

Education

Bachelor's degree in health/life science

GCP certification within 30 days

Clinical research regulatory experience (preferred)

Tools

Microsoft Office Suite

SharePoint

OneNote

Job description

Tennessee Oncology is seeking a Research Regulatory Coordinator to provide regulatory oversight for a network of oncology clinical trials from start-up to close-out. You will manage regulatory documents, submissions, approvals, amendments, and safety reporting while ensuring compliance with FDA, IRB, and institutional requirements across multiple protocols and phases.

As a liaison between investigators, sponsors, and regulatory bodies, you will drive timelines, inspection readiness, and