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University of Kansas Medical Center Regulatory Administrator in Wichita, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/11812551


rRegulatory Administrator




SOM KC Internal Medicine - Administration


Medicine Administration

Position Title:

Regulatory Administrator

Job Family Group:

Professional Staff

Job Description Summary:

The Department of Internal Medicine is seeking a Senior Regulatory Coordinator to support and manage complex clinical research portfolio in collaboration with our institutional structures, faculty, sponsors and the Internal Medicine Research Office. This position provides a full range of administrative support for the clinical research enterprise in the Internal Medicine Research Office, with primary emphasis in ensuring the adequate support to IM faculty while strategically outlining resources for the development of clinical research in accordance to intuitional, federal, state, or other extramural sponsors policies and guidelines. Key responsibilities leading and performing study-specific regulatory, safety reporting, and quality improvement activities, and fiscal management in support of clinical research enterprise within the Department of Internal Medicine.

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. This position 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 maintenance of regulatory records throughout the life project for assigned cost centers.

The successful candidate should have superior organizational skills, excellent leadership qualities, and be able to efficiently manage competing priorities. In addition, they will be able to operate with autonomy, evaluate and prioritize responsibilities and build strong relationships with stakeholders under limited oversight from Manager.

Job Description:

Required Qualifications:

+ Education/Work Experience: Bachelor's Degree plus 4 years' related work experience OR 8 years' related work experience.

+ Skills:

+ Strong oral and written communication skills; good judgment; analytical problem-solving ability; and ability to provide high quality service in a timely manner is required.

+ In-depth understanding of regulations governing clinical research (CFR, GCP, HIPAA).

+ Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.

+ Experience working in a University or large academic institution

+ Understanding of the Federal Regulatory Code, FDA processes for submission of IND/IDE

+ IRB knowledge, Velos, O2

Preferred Qualifications:

+ Education: Preferred Degree(s) Master's Degree (Finance, Business Administration, Management)

+ Work Experience: Years of Experience in Work Field(s) 5-8 years' experience in large clinical unit within academia or research administration

+ Skills:

+ Workday Systems, Velos and Master Excel

+ Certified: CRA, CCRP, CCRC

Job Duti s Outlined:

+ Assisting PI with investigator-initiated studies across multiple agencies, including protocol development, reviewing consent forms, budget planning and following.

+ 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

+ Serves as a mentor to junior regulatory coordinators. May assign, review, and train others in various work responsibilities and provide constructive feedback to other team members

+ Support internal implementation of general principles of GAAP standards in reviewing financial compliance and consistency with contracts/agreements over the life of the