Clinical Research Regulatory Specialist

About OneOncology

OneOncology aims to empower community oncologists to transform medical care by adopting a patient-focused, physician-led, and technology-driven approach to enhance the lives of individuals affected by cancer and other illnesses. Our organization unites market leaders to support our mission and vision of advancing oncology care.

This is a unique opportunity to join OneOncology during an impactful growth phase, supported by experts in oncology, urology, technology, and finance. We seek motivated professionals eager to innovate and refine processes that assist independent physicians and their patients.

Role Overview

The Clinical Research Regulatory Specialist will partner with the OneR operations team and OneOncology practices to manage clinical research regulatory oversight across our network. This role is vital in ensuring all clinical research activities comply with established regulatory standards and guidelines. The person will liaise with multidisciplinary teams to streamline regulatory procedures from study initiation through completion, fostering strong collaboration with practices in our network.

Key Responsibilities

• Ensure strict compliance with regulatory mandates including FDA regulations, ICH guidelines, and local authorities.
• Prepare, submit, and maintain essential regulatory documents such as IND applications, amendments, and annual reports.
• Manage regulatory submissions to authorities and ethics boards, guaranteeing accuracy and timeliness.
• Review clinical trial protocols and informed consent forms to verify adherence to regulatory standards.
• Revise informed consent documents to enhance clarity on payments, costs, and standard of care, ensuring they include all FDA-required elements.
• Facilitate submission of regulatory documents to sponsors and CROs on behalf of network practices.
• Work closely with investigators and study teams resolving regulatory challenges and advising on compliance.
• Coordinate start-up regulatory activities, such as obtaining approvals, organizing binders, and confirming site regulatory compliance.
• Maintain comprehensive, up-to-date regulatory documentation that complies with all standards.
• Implement and manage an electronic regulatory binder system for secure document storage and management.
• Monitor and communicate regulatory submission schedules and progress to internal stakeholders.
• Provide training to study teams and investigators on regulatory requirements and best practices.
• Keep abreast of changes in regulations and industry standards and share relevant updates with the team.
• Build and sustain collaborative relationships across our network to optimize regulatory workflows.
• Perform additional duties contributing to our mission of enhancing care for cancer patients.

Qualifications and Experience

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field is mandatory; advanced degrees are preferred.
• At least 1-2 years of relevant experience in clinical research focused on regulatory affairs and compliance.
• Proficiency with Microsoft Office and familiarity with electronic data capture systems, regulatory binder systems, and clinical trial management software is desirable.
• Certification from recognized clinical research organizations (e.g., SoCRA, ACRP) is advantageous.

Core Competencies

• In-depth knowledge of clinical trial procedures, FDA and ICH-GCP regulations, and industry standards.
• Meticulous attention to detail combined with strong organizational capabilities.
• Excellent verbal and written communication skills enabling effective cross-functional collaboration.
• Capability to work both autonomously and within teams in a dynamic, fast-paced setting.