Compliance Coordinator - ICTS Regulatory Core

UIOWA•Iowa City, IA

1d•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 position helps establish and grow the department’s research core and supports research innovation. Work is performed under the direction of senior compliance coordinators and includes regulatory submissions, compliance monitoring, document maintenance, study start-up and maintenance, and support for internal and external review processes. The coordinator assists with investigating, remediating, and reporting complaints and reviews; monitoring compliance with local, federal, and sponsor-specific regulatory guidelines; resolving basic monitoring and audit issues; coordinating sponsor audit and monitor visits; evaluating deviations; and maintaining regulatory files and binders, including converting materials to electronic files when directed. The role also assists with basic risk assessment and protocol problem-solving, prepares study and recruitment materials, and supports IRB approval of recruitment resources. The position opens, maintains, and closes clinical trials under senior team members’ direction. 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 continued reviews. Duties include preparing and submitting human-subjects review materials to IRBs and application forms to other relevant institutional committees; assisting with protocol reviews, modifications, adverse events, safety reports, and other reportable events; and preparing regulatory requests and correspondence. The coordinator may collaborate with investigators, clinicians, research staff, sponsors, and national agencies, assist with regulatory metrics analysis using the ICTMS database, and attend or contribute to assigned meetings. The role also provides basic policy information to sponsors, principal investigators, and study team members, and prepares and delivers basic training content and resources to support understanding of and adherence to applicable standards and regulations. The ICTS at the University of Iowa supports clinical and translational science through workforce development, community and stakeholder engagement, research integration, and innovative research.

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 institutional review boards 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 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.
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 working with University of Iowa systems, policies, procedures, and administrative processes.

Responsibilities

Assist with investigating, remediating, and reporting complaints and reviews.
Monitor 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 sponsor on-site audits and monitor visits.
Evaluate basic deviations and maintain regulatory files and binders; assist with electronic file conversion as directed.
Identify basic data problems and implement changes with direction; assess basic protocol-related problems.
Develop basic study and recruitment materials and resources, as directed, and help obtain IRB approval for recruitment resources.
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 IRBs and other institutional review committees, as directed.
Assist with preparation and submission of protocol annual reviews, modifications, adverse events, safety reports, and other reportable events 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, medical personnel, sponsors, and national agencies to support clinical research studies.
Assist senior compliance coordinators with analysis of clinical research metrics in the ICTMS database related to regulatory review and submission.
Attend and contribute to assigned meetings and assist with creating meeting materials and reporting study updates.
Provide sponsors, principal investigators, and study team members with information about policies in response to basic inquiries.
Prepare and deliver basic training content, materials, and resources that support adherence to internal and external standards and regulations.