OneOncology ยท 14 hours ago
Research Contracts, Budgets & Quality Specialist
United States
Full-time
Hybrid
Entry, Mid Level
2+ years expOneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model. The Research Contracts, Budgets & Quality Specialist will support clinical research across the OneOncology network, ensuring adherence to quality standards, regulatory requirements, and best practices throughout the lifecycle of clinical trials.
Health CareOncology
Responsibilities
Assist in the development, implementation, and maintenance of quality management systems to ensure compliance with regulatory requirements, industry standards, and organizational policies
Participate in the development and review of standard operating procedures (SOPs), work instructions, and quality documents to promote consistency and compliance in clinical research operations
Conduct routine reviews and assessments of clinical trial documentation, data, and processes to identify areas for improvement and ensure accuracy, completeness, and compliance
Stay informed about current regulatory guidelines and requirements from FDA, EMA, ICH, and other relevant regulatory authorities
Assist in the interpretation and implementation of regulatory requirements to ensure adherence to applicable laws and guidelines throughout the clinical research process
Support regulatory inspections, audits, and inquiries by preparing documentation, facilitating site visits, and addressing findings as needed
Assist in developing training materials and resources on best practices in clinical research
Participate in the delivery of training sessions to clinical research staff to enhance their understanding of quality standards, regulatory requirements, and organizational policies
Provide guidance and support to clinical research personnel on quality-related issues, procedures, and documentation requirements
Assist in the planning, execution, and follow-up of internal and external audits
Prepare audit plans, checklists, and reports to document audit findings, observations, and recommendations for corrective and preventive actions
Qualification
Required
Minimum of 2-3 years of experience in clinical research, quality assurance, or regulatory affairs
Bachelor's degree in a relevant scientific discipline required
Proficiency in Microsoft Office applications
Ability to travel ~25%
Preferred
Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
Company
OneOncology
OneOncology is a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the US. It is a sub-organization of General Atlantic.
1001-5000 employees
H1B Sponsorship
OneOncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Cencora
2025-12-12Acquired
2023-04-20Secondary Market
Leadership Team
Davey Daniel
Chief Medical Officer
Recent News
2026-01-05
2025-12-18
Company data provided by crunchbase