Job Description Summary:
The Department of Internal Medicine is seeking a Clinical Research Administrator 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 regulatory components 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 maintenances 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 Leadership.
Job Description:
Required Qualifications:
Education/Work Experience: Bachelor’s Degree plus 4 years' related work experience OR an equivalent combination education and 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.
Ability to act in solving problems while exhibiting judgment and a realistic understanding of issues
Experience working in a university or large academic institution
In-depth understanding of regulations governing research (Understanding of the Federal Regulatory Code, FDA processes for submission of IND/IDE, GAAP, Uniform Guidance, HIPPA)
IRB knowledge, Velos, O2, Huron Research Suite, Workday, and Excel
Preferred Qualifications:
Education: Preferred Degree(s) Master’s Degree (Finance, Business Administration, Management)
Work Experience: Years of Experience in Work Field(s) 3-5 years’ experience in large clinical unit within academia or research administration
Skills:
Huron Research Suite, Workday, Velos, and Excel
Certified: CRA, CCRP, CCRC
Job Duties Outlined:
Under general guidance and with latitude for the exercise of independent judgment and initiative:

Assisting 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.
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 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.
Other duties as assigned.