Senior Compliance Coordinator - ICTS Regulatory Core

University of Iowa; Iowa City (IA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Paid vacation

Health insurance

Dental insurance

Retirement contributions

Job summary

The Senior Compliance Coordinator I in ICTS at the University of Iowa will coordinate and manage regulatory activities for multiple clinical trials, including IRB submissions, adverse event reporting, and sponsor communications, to ensure strict regulatory compliance.

You will develop and implement policies, provide staff training, and maintain regulatory documentation while using systems such as OnCore, eReg, REDCap, and Epic.

Qualifications

• Experience with preparing submissions for IRB and other ethical applications (3+ years).
• Experience processing research regulatory documents (3+ years).

Responsibilities

• Monitor compliance with local, federal, institutional and sponsor requirements.
• Investigate protocol deviations and reportable events.
• Coordinate audits, monitoring visits and FDA inspections.
• Prepare regulatory submissions and maintain regulatory files.
• Develop and maintain study materials and consent documents.
• Lead or participate in regulatory trainings and policy development.

Skills

Regulatory affairs

GCP knowledge

Regulatory documentation

Project coordination

Tools

OnCore

eReg

REDCap

Epic

I-CART

CCRP Certification

Job description

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 the I nstitute for C linical and T ranslational S cience. This position will provide support for the I nstitute for C linical and T ranslational S cience 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 Reviews

Independently 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 Regulations

Provide 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 & Policies

Independently 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 Development

Assess 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 Programs

Develop 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 Management

Coordinate 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.

-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?

Experience, 3 years, preparing submissions for institutional review board and other ethical applications.

Experien ce, 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 Qualifications

Experience with OnCore, eREG, REDCap, Epic and I-CART.

CCRP Certification

Previous experience working with University of Iowa systems, policies, procedures, and administrative processes.

Additional Information

• Classification Title: Senior Compliance Coordinator
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

Contact Information

Equal opportunity employer

The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and 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, [phone] or [e-mail] . For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543 .