Note: The job is a remote job and is open to candidates in USA. OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model. The Clinical Research Regulatory Specialist will collaborate with the operations team and practices to ensure compliance with regulatory requirements for clinical research projects, facilitating processes from study initiation to completion.
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 readability, clarification of payments, costs, and standard of care language, and to ensure that all elements required by the Food and Drug Administration (FDA) are included
- Prepare, route, and submit essential regulatory documents to sponsors/CROs on behalf of network practices
- Collaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirements
- Coordinate regulatory activities during study start-up, including obtaining regulatory approvals, organizing regulatory binders, and ensuring site compliance with regulatory requirements
- Maintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standards
- Establish and maintain an electronic regulatory binder system to securely store and manage regulatory documents and submissions
- Track and communicate regulatory submission timelines, milestones, and status updates to internal stakeholders
- Provide training and support to study teams and investigators on regulatory requirements, procedures, and best practices
- Stay informed about changes in regulatory requirements and industry standards, and disseminate relevant information to team members
- Cultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaboration
- Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer
Skills
- 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
- 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
- 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
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