Cancer Clinical Trials Regulatory Coordinator

Highlands Oncology Group; Springdale (AR); On-site; USD 52,000 - 75,000; Full time

Job summary

Highlands Oncology Group is seeking a Research Regulatory Coordinator to ensure regulatory documentation and compliance for clinical trials, aligning with GCP, Highlands policies, and sponsor requirements. The role supports the coordination of regulatory binders, IRB submissions, and sponsor communications.

You will interact with PI, sponsors, patients, CRAs, and IRB, maintaining up-to-date protocol and consent form versions across sites.

Qualifications

• Demonstrates professionalism and responsiveness when interacting with internal and external customers.
• Advises supervisor or other appropriate individuals of problems or concerns.
• Collaborates effectively with physicians, nurses, and ancillary departments.

Responsibilities

• Performs all study-start-up activities – initial IRB Submission, initial FDA Form 1572, initial Financial Disclosure Forms.
• Submits protocol/ICF changes to the IRB in a timely manner.
• Maintains organized files and office space; coordinates sponsor site initiation visits.

Skills

Communication

Organization

Professionalism

Accountability

Regulatory knowledge

Education

High school diploma or higher

Tools

EMR systems

Job description

Highlands Oncology Group is seeking a Research Regulatory Coordinator to ensure regulatory documentation and compliance for clinical trials, aligning with GCP, Highlands policies, and sponsor requirements. The role supports the coordination of regulatory binders, IRB submissions, and sponsor communications.

You will interact with PI, sponsors, patients, CRAs, and IRB, maintaining up-to-date protocol and consent form versions across sites.