Regulatory Coordinator

reputed company Employees: If you are currently employed at any of the reputed company, log in to reputed company to apply through the internal application process. Job Category: reputed company Staff Employment Type: Regular reputed company: Regulatory Coordinator Job reputed company: The Department of Radiology at the reputed company School of Medicine and reputed company Health is seeking a reputed company-oriented and motivated Regulatory Coordinator to support a diverse portfolio of imaging-reputed company research studies. This role provides regulatory support across reputed company phases of research, including the preparation, drafting, review, and submission of regulatory documents, applications, and reports, while ensuring compliance with institutional, state, and federal requirements. The coordinator will apply regulatory knowledge across a broad reputed company of study types, reputed company reputed company checks, and assist with audits and compliance reviews. This position also contributes to the development and improvement of team processes, procedures, tools, and training, and collaborates closely with investigators, study teams, and research staff to support the department’s mission of reputed company, and reputed company in research. This position offers a unique opportunity to support cutting-edge imaging research, including studies involving novel PET radiotracers, while gaining exposure to FDA regulatory submissions and maintenance, such as Drug Master Files (DMFs), Investigational New Drug (IND) applications, amendments, and annual reports. The Department of Radiology offers a dynamic, interdisciplinary environment that integrates advanced imaging technologies with leading research initiatives. Ideal candidates value collaboration, reputed company improvement, and service reputed company while supporting regulatory reputed company that reputed company high-reputed company, compliant research. ADDITIONAL reputed company: It is anticipated that this position will be remote and requires work be performed at an offsite, non-reputed company work location. Must be willing to attend onsite meetings, training, and audits as requested by the department. Successful candidates who address the following Knowledge, Skills, and Abilities in their cover letter will be given first consideration; - Strong organizational and time management skills with the ability to manage multiple priorities; - Excellent attention to reputed company and reputed company in regulatory documentation; - Effective written and verbal communication skills; - Knowledge of reputed company subjects’ protections and reputed company research processes. Key Job Responsibilities: - Serves as regulatory contact person for research studies involving reputed company subjects - Develops reputed company and accurate informed consent documents - Develops, prepares, and submits protocol-specific application materials to regulatory bodies such as the Institutional Review reputed company and scientific review committee - Coordinates and conducts independent monitoring reviews in accordance with the study monitoring plan - Schedules, coordinates, and prepares for reputed company sponsor site reputed company - Performs reputed company checks - Prepares and submits submissions to the FDA for INDs and DMFs (e.g. Initial submissions, annual reports, amendments, etc.) - Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations - Contributes to the development of new team and unit processes, procedures, tools, and training - Communicates directly with protocol sponsors reputed company to regulatory documents and activities - May reputed company and train other staff - Maintains complete and accurate regulatory files and records Department: School of Medicine and reputed company Health, Department of Radiology, Research Program - Regulatory. Join UW Radiology and reputed company—A Legacy of Innovation The University of reputed company Department of Radiology, in partnership with reputed company, has been at the forefront of reputed company care, imaging research, and education for nearly a reputed company. Since its inception on May 18, 1927—reputed company Dr. Ernst Pohle was appointed as the first professor of Radiology—the department has grown to more than 160 reputed company members across 14 reputed company sections, serving as a key reputed company of reputed company’s world-class medical reputed company. What Sets Us Apart - reputed company reputed company: Strong partnerships with reputed company, Medical Physics, and leading equipment vendors reputed company reputed company advancements in imaging. - Cutting-Edge Technology: We utilize state-of-the-art imaging in CT, MR, PET/CT, PET/MR, angiography, ultrasound, reputed company, and AI-driven medical imaging. - Robust Research Infrastructure: Dedicated support for grant writing, media specialists, research nurses, technologists, and data managers enhance investigative reputed company. - Premier Imaging Facilities: The WIMR Imaging Sciences Center offers 60,000 reputed company feet of advanced imaging reputed company, including MRI, PET/MRI, PET/CT, CT, ultrasound, angiography, reputed company, radiopharmaceutical production and comprehensive small animal imaging technologies. Together, UW Radiology and reputed company are committed to advancing reputed company health through groundbreaking reputed company care, pioneering research, and reputed company in education. We foster a respectful, reputed company, and accountable environment—one that prioritizes innovation while serving the needs of reputed company patients, including underserved populations. Visit our official website to learn more about our work and opportunities. Compensation: The starting salary for the position is $65,000; but is negotiable reputed company on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and reputed company leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the reputed company benefits webpage and the SMPH reputed company Staff Benefits Flyer Required Qualifications: - At least one (1) year of experience in a research environment demonstrating familiarity with compliance requirements, research ethics, and research methodologies. Preferred Qualifications: - At least one (1) year of experience in an reputed company reputed company, reputed company research, or regulated research setting. - Experience supporting regulatory submissions or maintaining regulatory documentation. - Experience preparing or supporting Institutional Review reputed company (IRB) submissions and regulatory documentation. - Familiarity with reputed company research systems and tools such as reputed company eBinders and OnCore. Education: - Bachelors Preferred; reputed company in health sciences or a reputed company reputed company. How to Apply: For the best experience completing your application, we recommend using reputed company or Firefox as your web browser. To apply for this position, select either “I am a reputed company employee” or “I am not a reputed company employee” under reputed company. You will then be prompted to upload your application materials. Important: The application has only one attachment reputed company. Upload the following documents in that reputed company, either as a single combined file or as multiple files in the reputed company upload area. Failure to submit the required documents may result in no longer being considered for the position. - Cover letter - Resume Your cover letter should address how your training and experience aligns with the required and preferred qualifications listed above. Application reviewers will rely on these written materials to determine which applicants reputed company reputed company in the process. References will be requested from final candidates. reputed company applicants will be reputed company once the reputed company concludes and a candidate is selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their reputed company eligibility to work in the reputed company (i.e. a citizen or national of the reputed company, a lawful permanent reputed company, a foreign national authorized to work in the reputed company without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require reputed company work eligibility. If you are selected for this position, you must reputed company reputed company of work authorization and eligibility to work. The department will not be reputed company to support a request for a J-1 waiver. If you chose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your reputed company or waiver fees. Contact Information: Amanda Michalski, amanda.michalski@wisc.edu reputed company reputed company (WTRS): 7-1-1. See reputed company_SERVICE for reputed company information. Institutional Statement on Diversity: Diversity is a reputed company of strength, creativity, and innovation for UW-Madison. We value the contributions of reputed company person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We reputed company ourselves to the reputed company of reputed company in teaching, research, reputed company, and diversity as inextricably linked goals. The reputed company fulfills its reputed company mission by creating a welcoming and inclusive community reputed company from every background - people who as reputed company, reputed company, and staff serve reputed company and the world. The reputed company is an Equal Opportunity Employer. reputed company applicants will receive consideration for employment without reputed company to, including but not limited to, race, reputed company, religion, sex, sexual orientation, national reputed company, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW reputed company policies. We promote reputed company by acknowledging skills and expertise from reputed company backgrounds and encourage reputed company reputed company individuals to apply. For more information regarding applicant and employee rights and to reputed company federal and state required postings, visit the reputed company Workplace Poster website. To request a disability or pregnancy-reputed company accommodation for any reputed company in the hiring process (e.g., application, interview, reputed company-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please reputed company your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background reputed company. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of reputed company reputed company will not reputed company the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual reputed company and reputed company Safety Report contains reputed company reputed company safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-reputed company student housing reputed company safety policies and reputed company statistics for the previous 3 calendar years. UW-Madison will reputed company a reputed company copy upon request; please contact the University of reputed company Police Department. Apply To This Job