**Job Summary** The Regulatory Affairs Coordinator will act as liaison between NEXT Oncology (an Avacare business), the Institutional Review Board, and various Pharmaceutical and Biotech companies (Sponsors) to open clinical trials at NEXT Oncology. **Essential Duties and Responsibilities** + Submit new studies to the Institutional Review Board (IRB) for approval. + Submit changes to the protocol, informed consent forms, investigator’s brochures, serious adverse event reports, safety reports (i.e., SUSARs or similar reports), and protocol deviations to the IRB. + Ensure studies are kept open at the IRB by submitting continuing review reports on time. + Submit closure notifications to the IRB as necessary when applicable. + Give tours of NEXT Oncology to clinical trial Sponsors and other visitors as applicable. + Complete feasibility questionnaires for proposed clinical trials. + Set up Protocol Review and Feasibility Committee meetings as needed. + Enter study-specific information (such as but not limited to, study title, assigned staff, documents received from Sponsor, IRB submission/approval dates, etc.) in internal FileMaker database to provide a complete history of each clinical trial. + Set up official regulatory files in our electronic regulatory files system (eDOCS) for clinical trials being conducted at NEXT Oncology once a study is approved by the IRB. + Set up access for NEXT Oncology staff in eDOCS to ensure most current documents are available to all staff. + Set up access for Sponsors and their representatives in eDOCS once the Site Initiation Visit has occurred. + Complete various documents (such as but not limited to: Delegation of Authority Logs, Form FDA 1572s, Financial Disclosure Forms, etc.) for clinical studies being conducted at NEXT Oncology. + Maintain current certifications and ranges for all laboratories being used in the conduct of clinical trials at NEXT Oncology. + Maintain current CVs and Medical Licenses for investigators. + Maintain current training documents (GCP, HRS, etc.) in eDOCS for all NEXT Oncology staff. + Work with Research Coordinators to ensure training documentation provided to the Regulatory Department is accurate. + Receive incoming correspondence/files and review/forward to appropriate staff. + Attend Phase I meetings, Site Qualification Visit meetings, Site Initiation Visit meetings, and other meetings as applicable. + Perform a variety of administrative duties including but not limited to: answering phones; faxing and filing of confidential documents; and basic Internet and email utilization. + Provide excellent customer service to all internal and external customers. **Required Education and Experience** + Bachelor’s degree in administration or science. + Three years’ experience in a medical or research setting preferred but not required. **Why Join Us?** At NEXT Oncology (an Avacare Business), you’ll be part of a mission-driven team that values collaboration, precision, and patient safety. Our team is known for its supportive culture, strong communication, and commitment to excellence in clinical research. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe The potential base pay range for this role, when annualized, is $46,200.00 - $96,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled