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 theInstitute 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.

Duties to include but not limited to:

·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.

For a full job description, please send an e-mail to the contact listed below.

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.

Percent of Time: 100%

Pay Grade: 4B

https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights:

-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?, click here

Required Qualifications

·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.

Desirable Qualifications

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

·CCRP Certification

Application Process:

In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:

Resume

Cover Letter

Job openings are posted for a minimum of 7 calendar days and may be removed from positing and filled any time after the original posting period has ended.

Successful candidates will be required to self -disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.Hybrid within Iowa: This position is eligible for a combination of on-campus and remote work. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies

For additional questions, please contact Amy Stewart at amy-stewart@uiowaedu

This position is not eligible for University sponsorship for employment authorization.