Senior Compliance Coordinator - ICTS Regulatory Core

University of Iowa•Iowa City, IA

1d•Hybrid

About The Position

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 Institute for Clinical and Translational Science. This position will provide support for the Institute for Clinical and Translational Science 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.

Requirements

A bachelor’s degree in a Health Science field or an equivalent combination of education and research experience is required.
Excellent written, verbal, and interpersonal communication skills.
Proficient in computer software applications including spreadsheet and database experience.
Understanding of and ability to handle confidential information.
Experience in coordinating multiple projects and functions independently.
Excellent organizational skills. Ability to work independently.
Experience, typically 2 plus years, preparing submissions for institutional review board and other ethical applications.
Experience, typically 2 plus years, in processing research regulatory documents.
Proficiency in regulatory affairs with ability to work independently.
Proficiency in Good Clinical Practice (GCP) in research
Excellent time management skills and ability to perform detail-oriented work.

Nice To Haves

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

Responsibilities

Monitor compliance with complex regulatory guidelines, including local, federal, and sponsor-specific guidelines and ensure proper maintenance of documents.
Coordinate FDA inspections.
Collaborate with the study team to identify complex data problems and implement change as needed. Make recommendations for query resolution within the EDC.
Assist the Principal Investigator and study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures. Advising PI’s in the regulatory compliances required for the specific study.
Responsible for opening, maintaining, and closing clinical trials; may train and provide guidance to others as needed. The PNB2 Coord. I should be capable of maintaining 6-10 studies simultaneously: should be capable of modifying 9-15 existing studies and/or continued reviews.
May provide cross coverage support within regulatory team as needed.
Assess effectiveness of policy/procedure.
Assist in the development of policy/procedure as assigned.
Assist in training efforts/onboarding new staff members.
Prepare and deliver complex content that enhances knowledge of and adherence to internal and external standards and regulations.
Work with financial analyst assigned to studies to ensure items are included in the budget and they are aware of all procedures that could be billed as research. Create accounts in iCart for users to track study specific funding/budgets.