Clinical Research Jobs at OneOncology, USA | Regulatory Specialist | Life Sciences | Apply Now
A rare chance to join OneOncology as a Clinical Research Regulatory Specialist: is now available in the United States. This role is pivotal for those interested in clinical research jobs and regulatory affairs, providing an opportunity to contribute to improving patient care in oncology.
- Job Position: Clinical Research Regulatory Specialist
- Location: United States
- Job Requisition ID: R-0000023031
About The Company
OneOncology is a leading organization dedicated to transforming cancer care by empowering community oncologists. Through a patient-centric, physician-driven, and technology-enabled approach, OneOncology aims to enhance the lives of patients battling cancer and other diseases. The organization is committed to innovation and excellence in clinical research, making it an ideal place for those seeking clinical research jobs in the United States.
Job Description
The Clinical Research Regulatory Specialist will collaborate with the OneR operations team and OneOncology practices to support clinical research across the OneOncology network. This role is essential in ensuring compliance with regulatory requirements and guidelines for clinical research projects. The specialist will work closely with cross-functional teams to facilitate the regulatory aspects of clinical trials, ensuring smooth and efficient processes from study initiation to completion. Engaging with various practices within the network will be crucial to streamline regulatory processes and foster collaboration.
Clinical Research Jobs – Key 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 clarity and compliance with FDA requirements.
- Collaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirements.
- Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards.
- Provide training and support to study teams and investigators on regulatory requirements, procedures, and best practices.
Eligibility Criteria Required For Clinical Research Jobs
- Bachelor’s degree in a relevant field e.g., life sciences required; advanced degree preferred.
- Minimum of 1-2 years of experience in clinical research, focusing on regulatory affairs and compliance.
- Proficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems preferred.
- Certification in clinical research (e.g., SoCRA, ACRP) is a plus.
Required Skills
- Strong understanding of clinical trial processes and regulatory requirements (e.g., ICH-GCP, FDA guidelines).
- 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.
Why Join OneOncology?
This is an exciting time to become part of OneOncology. The organization fosters a values-driven culture that reflects a startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. Talented individuals who are motivated to improve and build new processes that support the meaningful work of independent physicians and the patients they serve will find a fulfilling environment here.
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