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This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13202560

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rSenior Regulatory Coordinator - Comprehensive Integrated Research Operations (CIRO)

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Department:

Comprehensive Integrated Research Operations (CIRO)

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Administration

Position Title:

Senior Regulatory Coordinator - Comprehensive Integrated Research Operations (CIRO)

Job Family Group:

Professional Staff

Job Description Summary:

The Senior Regulatory Coordinator serves as the administrative resource and liaison involved in supporting the business aspects of the clinical research enterprise. Function encompasses activities related to the full life-cycle of clinical research administration and overall compliance with university policies, state and granting sponsoring agency. The Senior Regulatory Coordinator is responsible for leading and performing study-specific regulatory and study-specific regulatory and safety reporting for a group of investigators, within multiple cost centers in the Department of Internal Medicine. Responsible to ensure the research is compliant with applicable federal, state, or international requirements, while adhering to policies of the University of Kansas Medical Center. Assigned contact for study-start up activities including IRB/Ancillary committee submissions, and maintenances of regulatory records throughout the life project for assigned cost centers.

Job Description:

Job Duties:

Under general guidance and with latitude for the exercise of independent judgment and initiative:

• Assist PI with investigator-initiated studies across multiple agencies, including protocol development, reviewing consent forms, budget planning and following-up with system set-up.
• Interface with study sponsors and study team members during study start-up and maintenance regarding regulatory documents, other regulatory issues, or contract modifications. Provide updates as required, escalate as appropriate.
• Lead Internal Medicine\'s Quality Improvement activities for Clinical Research Enterprise.
• Perform start-up activities including submission of study documents to the Institutional Review Board, maintaining timeline goals and escalating delays appropriately, collaborating with team members to ensure regulatory documents are completed and accurate. Completion and maintenance of study file documents according to requirements of ICH GCP E6 and Regulatory Agencies\' guidance and standards.
• Update protocol and study information into the Clinical Trial Management System (Velos) for team collaboration.
• Provide assistance to study monitors during routine monitor visits or audits.
• Support internal implementation of general principles of GAAP standards in reviewing financial compliance and consistency with contracts/agreements over the life of the project, following institutional and sponsor guidelines.
• Support the management or perform analytical and financial activities associated with cost studies, forecasting, planning, and managing clinical portfolios, including close-out of projects.
• Facilitate reporting and updates to study teams on the financial status of the clinical projects.
• Manage or perform activities related to multiple areas of clinical research projects administration including, multi-dimensional in nature, typically include various cross-functional duties and responsibility.
• This job description is not designed to contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibil ties, duties, and assignments. Furthermore, job duties and responsibilities may change at any time with or without notice.

Required Qualifications

Education: Bachelor\'s Degree or an equivalent combination of relevant education and work experience.

Work Experience:

• Four (4) years related work experience.
• In-depth understanding of regulations governing clinical research (CFR, GCP, HIPAA, Understanding of the Federal Regulatory Code, FDA processes for submission of IND/IDE, GAAP, Uniform Guidance) as evidenced by application materials.
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience working in a university or large academic institution.

Preferred Qualifications

Education/Certifications:

• Master\'s Degree (Finance, Business Administration, Management)

Certifications: One of the following certifications:

• CRA
• CCRP
• CCRC

Work Experience:

• Five (5) experience in large clinical unit within academia or research administration
• Institutional Review Board knowledge, Huron Research Suite, Workday, Velos, Complion, and Excel

Skills

Strong oral and written communication