Research Regulatory Specialist

OneOncology is hiring a Clinical Research Regulatory Specialist to support clinical research across its network of oncology practices. The role manages regulatory submissions and documentation, advises investigators and site teams on compliance, and helps streamline clinical trial processes from study initiation through completion.

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

Preferred

• advanced degree preferred
• 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
• Experience in oncology industry is highly desired
• Experience with IBC preferred
• Advanced degree
• Microsoft Office
• Electronic data capture systems
• Electronic regulatory binder systems
• Clinical trial management systems
• Clinical research certification
• Oncology industry experience
• IBC experience

Benefits

• Remote position; selected candidate will work on Central Time Zone business hours.

Company

• Community oncology network supporting independent cancer practices
• Nashville, Tennessee, USA
• https://oneoncology.com/
• Founded in 2018
• 1001-5000 employees

Qualifications

• 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
• Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required
• 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
• Advanced degree preferred
• 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
• Experience in oncology industry is highly desired
• Experience with IBC 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.

Required skills

• ACRP Certification, Clinical Research, FDA Regulations, IBC, ICH-GCP, IRB Submissions, Microsoft Office, Oncology, Regulatory Affairs and Compliance, SoCRA Certification

Preferred skills

• Experience in oncology industry is highly desired, Experience with IBC preferred, advanced degree preferred

Experience

• 1-2 years