Compliance Coordinator - ICTS Regulatory Core

University of Iowa•Iowa City, IA

2d•Hybrid

About The Position

The Regulatory Compliance Coordinator I in the Institute for Clinical and Translational Science (ICTS) supports the ICTS regulatory team by coordinating and managing regulatory activities for clinical trials and research studies. The role helps establish the department’s research core and supports innovation through research activities. Work is performed under the direction of senior compliance coordinators and other senior regulatory team members. The coordinator assists with regulatory compliance monitoring, documentation, monitor visits and audits, deviation evaluation, protocol and data issue resolution, and maintenance of regulatory files. The position also supports study start-up, ongoing management, modifications, continuing reviews, required committee submissions, and preparation of regulatory documents. After entry-level training and onboarding, the coordinator is expected to be able to maintain 2–3 new studies, including start-up, simultaneously, and modify 4–5 existing studies and/or handle continued reviews. The role may involve developing study and recruitment materials, supporting IRB approval of recruitment resources, preparing research-related reports and submissions, coordinating with sponsors and internal stakeholders, contributing to research metrics analysis, attending meetings, sharing policy information, and preparing and delivering basic educational materials. This position is eligible for a combination of on-campus and remote work; remote work must be performed within Iowa and comply with the University’s remote work program and policies.

Requirements

Bachelor’s degree in Business Administration or Accounting, or an equivalent combination of education and experience.
At least 1 year of experience preparing submissions for an institutional review board and other ethical applications.
At least 1 year 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 handle sensitive and confidential information appropriately.

Nice To Haves

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

Responsibilities

Assist with monitoring compliance with local, federal, and sponsor-specific regulatory guidelines and ensure proper document maintenance.
Resolve basic monitor and audit issues related to regulatory activities.
Coordinate with sponsors for on-site audits and monitor visits involving research and clinical data.
Perform basic evaluations of deviations and maintain regulatory compliance documents, files, and binders; assist with electronic conversion of files as directed.
Identify basic data problems and implement changes with direction, and assess basic protocol-related problems.
Develop basic study and recruitment materials as directed, including resources intended to support recruitment and obtain IRB approval.
Open, maintain, and close clinical trials under the direction of senior regulatory team members.
Prepare and submit Human Subjects Review forms and application materials to Institutional Review Boards as directed.
Prepare and submit applications to the Clinical Research Unit and relevant institutional review committees under direction.
Assist with regulatory processes and document preparation for implementing and maintaining clinical trials and research studies.
As directed, prepare and submit annual reviews, modifications, adverse events, safety reports, and other reportable-event documents to the IRB within internal deadlines.
Assist with consent creation and sponsor negotiations, and prepare or manage regulatory requests to sponsors and correspondence to the IRB of record as directed.
Collaborate with clinicians, investigators, data managers, nursing staff, pharmacists, and other medical personnel to support research studies; liaise with University departments, sponsors, and national agencies under senior coordinator guidance.
Assist senior compliance coordinators with analysis of clinical research metrics through the ICTMS database related to initial regulatory review and submissions.
Attend and contribute to assigned meetings and assist with meeting materials and study updates for internal and external groups, training meetings, team meetings, and sponsor or CRO meetings.
Provide sponsors, principal investigators, and study team members with information about policies in response to straightforward inquiries.
Prepare and deliver basic educational content, materials, and resources that promote knowledge of and adherence to internal and external standards and regulations.