Research Regulatory Specialist
OneOncology
•Remote
About The Position
The Clinical Research Regulatory Specialist collaborates with the OneR operations team and OneOncology practices to support clinical research across the OneOncology network. This role helps ensure clinical research projects comply with regulatory requirements and guidelines and supports regulatory aspects of clinical trials from study initiation through completion. The Specialist also works with network practices to streamline regulatory processes and foster collaboration. This is a remote position, with work conducted during Central Time Zone business hours.
Requirements
- Bachelor’s degree in a relevant field, such as life sciences, pharmacy, or nursing.
- At least 1–2 years of clinical research experience, focused on regulatory affairs and compliance.
- At least 1 year of experience with IRB submissions.
- Strong understanding of clinical trial processes, regulatory requirements such as ICH-GCP and FDA guidelines, and industry standards.
- Exceptional attention to detail and organizational skills.
- Effective communication and interpersonal skills, including the ability to collaborate across multidisciplinary teams.
- Ability to work independently and collaboratively in a fast-paced environment.
Nice To Haves
- An advanced degree.
- Proficiency in Microsoft Office applications.
- Familiarity with electronic data capture (EDC) systems, electronic regulatory binder systems, and clinical trial management systems (CTMS).
- Clinical research certification, such as SoCRA or ACRP.
- Experience in the oncology industry.
- Experience with IBC.
Responsibilities
- Maintain knowledge of evolving regulatory requirements, including FDA regulations and ICH-GCP guidelines, and industry standards; share relevant updates and impact assessments with network team members.
- Manage a high-volume portfolio of regulatory activities, prioritize competing work, track timelines and milestones, anticipate risks, and communicate status updates and escalations to stakeholders.
- Prepare, submit, and maintain regulatory documents and tracking systems, including IRB and IBC applications, protocol amendments, renewals, and reportable events.
- Coordinate regulatory submissions to authorities, sponsor systems, and ethics committees to support timely and accurate study start-up and ongoing compliance.
- Assist in reviewing protocols, Investigator Brochures, patient-facing materials, and other study documents for regulatory feasibility and compliance.
- Analyze, draft, review, and negotiate study- and site-specific informed consent forms (ICFs) for readability, consistency, protocol compliance, and required FDA elements; evaluate payment, costs, research-related injury, privacy, and site-specific language.
- Establish, maintain, and audit a central electronic regulatory binder system to ensure regulatory files and documentation are accurate, complete, accessible, and compliant.
- Serve as a regulatory subject matter expert for investigators and site teams by providing guidance, training, and support; collaborate with OneR Quality to investigate and resolve regulatory issues.
- Build and maintain relationships across network practices to streamline regulatory workflows, improve communication, and promote cross-functional collaboration.
- Perform additional responsibilities as assigned in support of the network’s mission.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
