Job Description

Senior Compliance Coordinator - ICTS Regulatory Core - (26006063)

Description

The Senior Compliance Regulatory Coordinator I in the Institute for Clinical and Translational Science will be an integral member of the research team in the Institute for Clinical and Translational Science. This position will provide support for the Institute for Clinical and Translational Science by performing activities which are vitally important to establish the research core for the department, as well as to grow and foster innovation through research support endeavors. The Senior Compliance Regulatory Coordinator I will apply previous experience to coordinate and manage clinical trial and research study regulatory activities within the Institute for Clinical and Translational Science (ICTS) department.Duties to include but not limited to:Investigation, Remediation and Reporting of Complaints and ReviewsIndependently monitor compliance with complex local, federal, institutional, and sponsor-specific regulatory requirements and ensure proper maintenance of regulatory documentation.Independently investigate and evaluate complex protocol deviations, reportable events, and other regulatory compliance issues.Determine reporting requirements, recommend appropriate regulatory and corrective actions, and communicate findings and next steps to study teams.Coordinate with sponsors for audits, monitoring visits, and FDA inspections and assist in resolving complex regulatory findings or issues.Monitor and maintain regulatory files and documentation and provide guidance on appropriate record maintenance and electronic regulatory systems.Participate in the development, implementation, testing, and troubleshooting of clinical research systems and tools, including Advarra OnCore/eReg, and provide guidance to staff on system use.Consultation, Risk Assessment and Interpretation/Research of RegulationsProvide regulatory guidance to investigators, study teams, and departments on complex research questions.Interpret regulatory and institutional requirements, identify compliance risks, evaluate study-specific issues, and recommend appropriate regulatory approaches.Collaborate with investigators and study teams in the development, execution, administration, and maintenance of complex protocols and clinical studies.Identify and assess complex protocol and data issues and recommend appropriate changes to maintain regulatory compliance.Independently develop complex study and participant recruitment materials and guide these materials through required regulatory review and approval.Collaborate with study teams to identify complex data problems and recommend appropriate resolutions.Management of Clinical Trials and Internal/External Review Processes & PoliciesIndependently manage complex clinical trials from study start-up through closure, including approximately 6–8 studies/start-ups and 9–12 modifications and/or continuing reviews simultaneously.Manage complex aspects of external review and internal regulatory processes, including preparation and submission of Human Subjects Review forms and application materials to the Institutional Review Board (IRB).Prepare and coordinate submissions to the Clinical Research Unit (CRU), Pharmacy and Therapeutics Committee, Medical Radiation Protection Committee, Protocol Review and Monitoring Committee, Joint Office of Compliance, Nursing Research Committee, Pathology Committee, and other review committees as required.Independently prepare and submit regulatory documents for annual/continuing reviews, modifications, adverse events, safety reports, reportable events, and other required study activities.Develop and manage consent documents, including required institutional language and sponsor negotiations.Manage regulatory requests from sponsors and correspondence with the IRB of record.Serve as a regulatory liaison among investigators, study teams, clinicians, data managers, nursing staff, pharmacists, sponsors, participating University departments, and other internal and external partners.Track study milestones, approvals, reporting deadlines, and regulatory requirements to ensure studies remain compliant and on schedule.Generate and review research metrics and regulatory information using clinical research systems, including Advarra OnCore, eReg, REDCap, and Electronic Data Capture (EDC) systems.Lead or participate in internal and external meetings related to study updates, regulatory requirements, research operations, sponsors, and CROs.Prepare and submit PI-initiated FDA IND/IDE IRB applications.Independently manage multi-site/sIRB studies where the University of Iowa serves as the IRB of record.Serve as the primary regulatory point of contact for participating external sites, coordinate regulatory submissions and documentation requirements, provide guidance on applicable requirements, and coordinate regulatory communication between the University of Iowa and external institutions.Policy DevelopmentAssess the effectiveness of regulatory policies, procedures, and workflows and identify needed changes.Develop and update regulatory policies, procedures, workflows, and tools based on regulatory changes and operational needs.Identify new policies or procedures needed in response to regulatory changes or internal needs.Recommend and implement process improvements that support regulatory compliance, consistency, and operational efficiency.Training & Educational ProgramsDevelop and deliver regulatory training content that enhances knowledge of and adherence to internal and external standards and regulations.Provide regulatory training and onboarding for new and current research staff.Develop training materials, workflows, and educational resources for research staff and departments.Provide education and guidance on institutional policies, regulatory requirements, documentation standards, research systems, and regulatory processes.Human Resources and Financial ManagementCoordinate with financial staff assigned to studies to ensure research-related procedures and other study requirements are appropriately identified and included in study budgets.Communicate study procedures that may be billed as research to support appropriate budget and billing decisions.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 the work of investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, to promote engagement of community members and other stakeholders, to promote research integration across the lifespan, and to catalyze innovative clinical and translational research. These efforts will lead to the development of novel therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and, ultimately to measurable improvements in the health of Iowa and the nation.Percent of Time: 100%Pay Grade: 4Bhttps://hr.uiowa.edu/pay/guide-pay-plansBenefits Highlights:-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

Qualifications

Required QualificationsBachelor’s degree in Business Administration or Accounting or an equivalent combination of education and experience.Experience, 3 years, preparing submissions for institutional review board and other ethical applications.Experience, 3 years, in processing research regulatory documents.Excellent written, verbal, and interpersonal communication skills.Strong organizational, time management, and attention-to-detail skills, with the ability to independently coordinate multiple projects and priorities.Proficiency in computer software applications, including spreadsheets and databases.Knowledge of regulatory affairs and Good Clinical Practice (GCP) in clinical research, with the ability to work independently.Demonstrated ability to handle sensitive and confidential information appropriately.Desirable QualificationsExperience with OnCore, eREG, REDCap, Epic and I-CART.CCRP CertificationPrevious experience working with University of Iowa systems, policies, procedures, and administrative processes.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:ResumeCover LetterJob openings are posted for a minimum of 7 calendar days and may be removed from positing and filled any time after the original posting period has ended.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.Hybrid within Iowa: This position is eligible for a combination of on-campus and remote work. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies.For additional questions, please contact Amy Stewart at amy-stewart@uiowa.eduThis position is not eligible for University sponsorship for employment authorization.

Primary Location

: Iowa City

Job

: Administrative/Professional

Organization

: Healthcare

Schedule

: Regular

Full-time

Job Posting

: Nov 5, 2026, 7:39:57 PM