Senior Compliance Coordinator - ICTS Regulatory Core
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.
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.
· 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
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· 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
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.
For additional questions, please contact Amy Stewart at amy-stewart@uiowa.edu
This position is not eligible for University sponsorship for employment authorization.
Equal opportunity employer
The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
