Research Regulatory Specialist

OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.

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, urology, 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 independent physicians 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 and maintain continuous knowledge of evolving regulatory requirements (including FDA regulations and ICH-GCP guidelines) and industry standards, proactively disseminating relevant updates and actional impact assessment to network team members.
• Manage a high-volume portfolio of regulatory activities with competing priorities and tight deadlines. Establish priorities, track timelines and milestones, anticipate risks, and communicate clear status updates and escalations to internal and external stakeholders.
• Prepare, submit, and maintain regulatory documents and tracking systems, such as Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) applications, protocol amendments, renewals, and reportable events.
• Coordinate and expedite regulatory submissions to regulatory authorities, sponsor systems, and ethic committees to ensure timely, accurate study start-up and ongoing compliance.
• Assist in the review of Protocols, Investigator Brochures (IBs), patient-facing materials, and other study-related documents to evaluate regulatory feasibility and ensure compliance with established standards.
• Analyze, draft, review, and negotiate study- and site-specific ICFs for readability, internal consistency, compliance with protocol requirements, and all elements required by the FDA. Evaluate payment, cost, research-related injury, privacy, and site-specific language to mitigate risk and align with Sponsor, OneOncology, and site requirements.
• Establish, maintain, and audit a central electronic regulatory binder system to ensure all regulatory files and documentation are stored, accurate, complete, and fully compliant with regulatory standards.
• Serve as the regulatory Subject Matter Expert (SME) for investigators and site teams, providing proactive guidance, training, and support on compliance requirements while collaborating closely with OneR Quality to investigate and resolve any regulatory issues.
• Cultivate and maintain strategic relationships across network practices to streamline regulatory workflows, break down communication silos, and promote cross-functional collaboration.
• Perform additional responsibilities as assigned to help drive our network’s 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.
  

Required 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.
• At least 1 year of experience with IRB submissions.
• Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems, electronic regulatory binder system, and clinical trial management systems (CTMS) preferred.

Preferred Qualifications:

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

Experience in oncology industry is highly desired.

Experience with IBC preferred.

Additional notes:

This is a remote position but selected candidate will work on Central Time Zone business hours.

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