Senior Compliance Coordinator - ICTS Regulatory Core

Senior Compliance Coordinator - ICTS Regulatory Core The Senior Compliance Regulatory Coordinator I in the Institute for Clinical and Translational Science will be an integral member of the research team in ICTS. This position will support ICTS by performing activities that establish the research core for the department and foster innovation through research support. The Senior Compliance Regulatory Coordinator I will apply previous experience to coordinate and manage clinical trial and research study regulatory activities within ICTS. Responsibilities Monitor compliance with complex regulatory guidelines, including local, federal, and sponsor-specific guidelines; ensure proper maintenance of documents. Coordinate FDA inspections. Collaborate with the study team to identify complex data problems and implement changes as needed; make recommendations for query resolution within the EDC. Provide cross-coverage support within the regulatory team as needed. Assess effectiveness of policy and procedures and assist in developing or updating them as assigned. Assist in training efforts and onboarding new staff members. Prepare and deliver complex content to enhance knowledge of and adherence to internal and external standards and regulations. Work with the financial analyst on studies to ensure items are included in the budget and that staff are aware of procedures that could be billed as research; create accounts in iCart for users to track study-specific funding and budgets. Qualifications Excellent written, verbal, and interpersonal communication skills. Proficient in computer software applications including spreadsheet and database experience. Understanding of and ability to handle confidential information. Experience coordinating multiple projects and functioning independently. Excellent organizational skills and ability to work independently. Experience (typically 2+ years) preparing submissions for institutional review board and other ethical applications. Experience (typically 2+ years) in processing research regulatory documents. Proficiency in regulatory affairs with ability to work independently. Proficiency in Good Clinical Practice (GCP) in research. Excellent time management skills and ability to perform detail-oriented work. Desirable Qualifications Experience with OnCore, eREG, REDCap, Epic and I-CART. Application Process In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process. This position is not eligible for University sponsorship for employment authorization. About ICTS The Institute for Clinical and Translational Science (ICTS) at the University of Iowa was approved by the Iowa Board of Regents in 2007 to support investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, promote community engagement, support research integration across the lifespan, and catalyze innovative clinical and translational research. These efforts aim to develop novel therapies and healthcare delivery strategies, integrate translational research and clinical practice, and improve health outcomes. Benefits - Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans. For more information about Why Iowa, click here. Equal Opportunity The University of Iowa is an equal opportunity employer. All qualified applicants will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences. Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services at View phone number on click.appcast.io or View email address on click.appcast.io. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at View phone number on click.appcast.io. #J-18808-Ljbffr