Compliance Coordinator - ICTS - Regulatory Core
University of Iowa

Job Info

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The Regulatory Compliance Coordinator 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 will coordinate and manage clinical trials and research study regulatory activities within the ICTS.

Duties to include but not limited to:

• Monitor compliance with regulatory guidelines and ensure proper maintenance of documents.
• Resolve monitor and auditing issues that relate to regulatory activities with assistance.
• Identification of data problems and implement change as needed, with assistance. Make recommendations for query resolution.
• Assess problems related to protocol.
• Responsible for opening, maintaining, and closing clinical trials.
• Manage specific aspects of external review and internal processes. Specifically, oversee the preparation and submission of the appropriate Human Subjects Review forms and application materials to the Institutional Review Boards.
• Provide information about policies to inquire with assistance.
• Prepare and deliver basic content that enhances knowledge of and adherence to internal and external standards and regulations.

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: 3B

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

Benefits Highlights:

- This position may be eligible to participate in a hybrid (partially remote) work schedule after one year of employment and a satisfactory performance record. Remote work must be performed at a location within the state of Iowa. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location.

-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

• Experience in computer software applications including spreadsheet and database experience.

• Understanding of and ability to handle confidential information.

• Experience in coordinating multiple projects and diverse functions independently.

• Excellent organizational skills. Ability to work independently.

• Excellent time management skills and ability to perform detail-oriented work is desired.

Desirable Qualifications

• 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.

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 14 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.

On Campus: This position may be eligible to participate in a hybrid (partially remote) work schedule after one year of employment and a satisfactory performance record. Remote work must be performed at a location within the state of Iowa. Per policy, work arrangements will be reviewed annually, and must comply with the remote work program and related policies and employee travel policy when working at a remote location.

For additional questions, please contact Amy Stewart at amy-stewart@uiowa.edu

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

Additional Information

• Classification Title: Compliance Coordinator
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: Hybrid within Iowa

Compensation

• Pay Level: 3B

Contact Information

• Organization: Healthcare
• Contact Name: Amy Stewart
• Contact Email: amy-stewart@uiowa.edu

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