Senior Compliance Coordinator - ICTS Regulatory Core

UIOWA•Iowa City, IA

12h•Hybrid

About The Position

The Senior Compliance Regulatory Coordinator I in the Institute for Clinical and Translational Science (ICTS) supports clinical and translational research by coordinating and managing complex clinical trial and research study regulatory activities. The role independently monitors compliance with local, federal, institutional, and sponsor-specific requirements; investigates and evaluates protocol deviations and other compliance issues; determines reporting requirements; recommends corrective and regulatory actions; and communicates findings to study teams. The coordinator also works with sponsors on audits, monitoring visits, and FDA inspections, maintains regulatory records, and supports clinical research systems such as Advarra OnCore and eReg. The position provides regulatory consultation to investigators, study teams, and departments, interpreting requirements, identifying compliance risks, and advising on protocols, study-specific issues, data problems, and participant recruitment materials. It manages complex clinical trials from start-up through closeout, including multiple concurrent studies, modifications, and continuing reviews. Responsibilities include preparing submissions and documents for the IRB and other institutional committees; managing consent documents and sponsor requests; tracking approvals, milestones, and deadlines; and serving as a regulatory liaison among internal and external partners. The role also manages multi-site and single-IRB studies where the University of Iowa is the IRB of record, including serving as the regulatory contact for external sites. Additional duties include assessing and developing regulatory policies, procedures, workflows, and tools; recommending process improvements; developing and delivering training for research staff; and coordinating with financial staff to identify research-related procedures and support appropriate study budgeting and billing decisions. The position is hybrid within Iowa, with a combination of on-campus and remote work permitted subject to University policies.

Requirements

Bachelor’s degree in Business Administration or Accounting, or an equivalent combination of education and experience.
Three years of experience preparing submissions for institutional review board and other ethical applications.
Three years of experience 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 appropriately handle sensitive and confidential information.

Nice To Haves

Experience with OnCore, eREG, REDCap, Epic, and I-CART.
CCRP certification.
Previous experience working with University of Iowa systems, policies, procedures, and administrative processes.

Responsibilities

Monitor compliance with complex local, federal, institutional, and sponsor-specific regulatory requirements and maintain regulatory documentation.
Investigate and evaluate protocol deviations, reportable events, and other regulatory compliance issues; determine reporting requirements and recommend appropriate regulatory and corrective actions.
Coordinate sponsor audits, monitoring visits, and FDA inspections, and assist with resolving regulatory findings or issues.
Maintain regulatory files and provide guidance on record maintenance and electronic regulatory systems.
Participate in the development, implementation, testing, and troubleshooting of clinical research systems and tools, and guide staff in their use.
Provide regulatory guidance to investigators, study teams, and departments; interpret requirements, identify compliance risks, and recommend regulatory approaches.
Collaborate with investigators and study teams on the development, execution, administration, and maintenance of complex protocols and clinical studies.
Identify complex protocol and data issues, recommend changes or resolutions, and develop participant recruitment materials for regulatory review and approval.
Manage complex clinical trials from study start-up through closure, including approximately 6–8 studies or start-ups and 9–12 modifications and/or continuing reviews simultaneously.
Prepare and submit Human Subjects Review forms and application materials to the IRB, and coordinate submissions to institutional review committees as required.
Prepare and submit continuing reviews, modifications, adverse events, safety reports, reportable events, and other required regulatory documents.
Develop and manage consent documents, including required institutional language and sponsor negotiations.
Manage sponsor regulatory requests and correspondence with the IRB of record.
Serve as a regulatory liaison among investigators, study teams, clinicians, data managers, nursing staff, pharmacists, sponsors, University departments, and other partners.
Track study milestones, approvals, reporting deadlines, and regulatory requirements.
Generate and review research metrics and regulatory information using clinical research systems, including Advarra OnCore, eReg, REDCap, and EDC systems.
Lead or participate in meetings about study updates, regulatory requirements, research operations, sponsors, and CROs.
Prepare and submit PI-initiated FDA IND/IDE IRB applications.
Manage multi-site/sIRB studies where the University of Iowa serves as the IRB of record, including serving as the primary regulatory contact for external sites and coordinating submissions, documentation, and communications.
Assess regulatory policies, procedures, and workflows; develop and update them in response to regulatory changes and operational needs; and implement process improvements.
Develop and deliver regulatory training, onboarding, materials, workflows, and educational resources for research staff and departments.
Coordinate with study financial staff to identify research procedures and study requirements for budgets, and communicate procedures that may be billed as research.