Compliance Coordinator - ICTS Regulatory Core

UIOWA • Iowa City, IA

8d • Hybrid

About The Position

The Regulatory Compliance Coordinator I in the Institute for Clinical and Translational Science will be an integral member of the regulatory team in the ICTS. This position will provide support for the regulatory team within the ICTS 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 Compliance Regulatory Coordinator I will coordinate and manage clinical trials and research study regulatory activities within the ICTS.

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.

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
• Experience in computer software applications including spreadsheet and database experience.
• Understanding of and ability to handle confidential information.
• Experience in coordinating multiple projects and a variety of functions independently.
• Excellent organizational skills. Ability to work independently.
• Excellent time management skills and ability to perform detail-oriented work.

Nice To Haves

• Experience with Oncore, eREG, REDCap, Epic and I-CART.
• Experience preparing submissions for institutional review board and other ethical applications.
• Experience in processing research regulatory documents.
• Experience in regulatory affairs.
• Working knowledge of Good Clinical Practice (GCP) in research.

Responsibilities

• Assist with monitoring compliance with basic regulatory guidelines, including local, federal, and sponsor-specific guidelines; ensure proper maintenance of documents.
• Resolve basic monitor and auditing issues that relate to regulatory activities.
• Identify basic data problems and implement change with direction.
• Assess basic problems related to protocol.
• Opening, maintaining, and closing clinical trials under the direction of the senior reg team members. After entry-level training/on-boarding is completed, the PNB1 Coord. I should be capable of maintaining 2-3 new studies, including start-up, simultaneously: also capable of modifying 4-5 existing studies and/or continued reviews.
• Prepare and submit appropriate Human Subjects Review forms and application materials to the Institutional Review Boards as directed by a senior compliance coordinator.
• Provide information to sponsors, PIs and study team members about policies from simple inquiries.
• Prepare and deliver basic content, materials and resources that enhances knowledge of and adherence to internal and external standards and regulations.

Benefits

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level