[Remote] Clinical Research Regulatory Specialist

Note: The job is a remote job and is open to candidates in USA. OneOncology is a company focused on improving cancer care through a patient-centric and technology-powered model. They are seeking a Clinical Research Regulatory Specialist to ensure compliance with regulatory requirements for clinical research projects and facilitate regulatory aspects of clinical trials across their network.ResponsibilitiesEnsure adherence to all relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory requirementsPrepare, submit, and maintain regulatory documents, such as investigational new drug (IND) applications, amendments, and annual reportsCoordinate regulatory submissions to regulatory authorities and ethics committees, ensuring timely and accurate completionAssist in the review of clinical trial protocols, informed consent forms, and other study-related documents to ensure compliance with regulatory standardsReview 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 includedPrepare, route, and submit essential regulatory documents to sponsors/CROs on behalf of network practicesCollaborate with investigators and study teams to address regulatory issues and provide guidance on regulatory requirementsCoordinate regulatory activities during study start-up, including obtaining regulatory approvals, organizing regulatory binders, and ensuring site compliance with regulatory requirementsMaintain accurate and up-to-date regulatory files and documentation, ensuring completeness and compliance with regulatory standardsEstablish and maintain an electronic regulatory binder system to securely store and manage regulatory documents and submissionsTrack and communicate regulatory submission timelines, milestones, and status updates to internal stakeholdersProvide training and support to study teams and investigators on regulatory requirements, procedures, and best practicesStay informed about changes in regulatory requirements and industry standards, and disseminate relevant information to team membersCultivate and maintain relationships with various practices within our network to streamline regulatory processes and promote collaborationOther duties as assigned to help drive our mission of improving the lives of everyone living with cancerSkillsBachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) requiredMinimum of 1-2 years of experience in clinical research, with a focus on regulatory affairs and complianceStrong understanding of clinical trial processes, regulatory requirements (e.g., ICH-GCP, FDA guidelines), and industry standardsExceptional attention to detail and organizational skillsEffective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teamsAbility to work independently and collaboratively in a fast-paced environmentAdvanced degree preferredProficiency in Microsoft Office applications and familiarity with electronic data capture (EDC) systems, electronic regulatory binder system, and clinical trial management systems (CTMS) preferredCertification in clinical research (e.g., SoCRA, ACRP) is a plusCompany OverviewNew York Oncology Hematology is the largest cancer and blood condition treatment center in the United States. It was founded in 1985, and is headquartered in Albany, New York, USA, with a workforce of 501-1000 employees. Its website is https://newyorkoncology.com/.