Senior Compliance Coordinator - ICTS Regulatory Core

University of Iowa•Iowa City, IA

1d•Hybrid

About The Position

The Senior Compliance Regulatory Coordinator I will be an integral member of the University of Iowa’s Institute for Clinical and Translational Science (ICTS) research team. The position supports the establishment and growth of the research core by coordinating and managing clinical trial and research study regulatory activities. The coordinator independently oversees complex regulatory compliance matters, including investigations of protocol deviations and reportable events, sponsor audits and inspections, regulatory documentation, risk assessment, and guidance to investigators and study teams. The role manages clinical trials from start-up through closure, prepares submissions and continuing reviews for the IRB and other review committees, supports multi-site studies, and serves as a regulatory liaison to internal and external partners. Responsibilities also include developing policies and process improvements, delivering training, supporting research systems, and coordinating with financial staff on study procedures and budgets. This position is hybrid within Iowa, combining on-campus and remote work. Remote work must be performed within Iowa and follow the university’s remote work 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 boards 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, including the ability to independently coordinate multiple projects and priorities.
Proficiency with 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.
Ability to handle sensitive and confidential information appropriately.

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

Independently monitor compliance with 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, recommend corrective actions, and communicate findings.
Coordinate sponsor audits, monitoring visits, and FDA inspections, and assist with resolving regulatory findings.
Maintain regulatory files and documentation and guide staff on records maintenance and electronic regulatory systems.
Participate in developing, implementing, testing, and troubleshooting clinical research systems and tools, including Advarra OnCore/eReg.
Provide regulatory guidance to investigators, study teams, and departments; interpret requirements, identify compliance risks, and recommend regulatory approaches.
Collaborate on the development, execution, administration, and maintenance of complex protocols and clinical studies.
Assess protocol and data issues, recommend changes or resolutions, and develop participant recruitment materials for regulatory review and approval.
Manage complex clinical trials from start-up through closure, including approximately 6–8 studies/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 relevant internal review committees.
Prepare and submit continuing reviews, modifications, adverse events, safety reports, reportable events, and other 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 concerning 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 and communications.
Assess regulatory policies, procedures, and workflows; develop and update them in response to regulatory changes or operational needs; and implement process improvements.
Develop and deliver regulatory training, onboarding, workflows, and educational resources for research staff and departments.
Coordinate with financial staff to identify research-related procedures and study requirements for budgets, and communicate procedures that may be billed as research.