Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.

Job Description:

The Clinical Research Regulatory Specialist will collaborate with OneR operations team and OneOncology practices to support clinical research across the OneOncology network. The Clinical Research Regulatory Specialist will play a crucial role in ensuring compliance with regulatory requirements and guidelines for our clinical research projects. The Clinical Research Regulatory Specialist will work closely with cross-functional teams to facilitate the regulatory aspects of clinical trials, ensuring smooth and efficient processes from study initiation through to completion. Additionally, they will engage with various practices within our network to streamline regulatory processes and foster collaboration.

Responsibilities

• Ensure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirements.

• Prepare, submit, and maintain regulatory documents, such as investigational new drug (IND) applications, amendments, and annual reports.

• Coordinate regulatory submissions to regulatory authorities and ethics committees, ensuring timely and accurate completion.

• Assist in the review of clinical trial protocols, informed consent forms, and other study-related documents to ensure compliance with regulatory standards.

• Review and modify study specific informed consent forms for readability, clarification of payments, costs, and standard of care language, and to ensure that all elements required by the Food and Drug Administration (FDA) are included.

• Prepare, route, and submit essential regulatory documents to sponsors/CROs on behalf of network practices.

• Collaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirements.

• Coordinate regulatory activities during study start-up, including obtaining regulatory approvals, organizing regulatory binders, and ensuring site compliance with regulatory requirements.

• Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards.

• Establish and maintain an electronic regulatory binder system to securely store and manage regulatory documents and submissions.

• Track and communicate regulatory submission timelines, milestones, and status updates to internal stakeholders.

• Provide training and support to study teams and investigators on regulatory requirements, procedures, and best practices.

• Stay informed about changes in regulatory requirements and industry standards, and disseminate relevant information to team members.

• Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration.

• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Key Competencies

• Strong understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standards

• Exceptional attention to detail and organizational skills

• Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams

• Ability to work independently and collaboratively in a fast-paced environment

Qualifications

• Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required; advanced degree preferred

• Minimum of 1-2 years of experience in clinical research, with a focus on regulatory affairs and compliance

• Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems, electronic regulatory binder system, and clinical trial management systems (CTMS) preferred

• Certification in clinical research (e.g., SoCRA, ACRP) is a plus.

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