This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13186797

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rSite Development and Feasibility Specialist - Research Administration

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Department:

RI Office of Clinical Trials Administration (OCTA)

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OCTA, Clinical Trial Management, Assistant Director

Position Title:

Site Development and Feasibility Specialist - Research Administration

Job Family Group:

Professional Staff

Job Description Summary:

The Site Development and Feasibility Specialist is responsible for growing the clinical research portfolio with research partners. This position will foster the development of clinical trial feasibility processes and resources across the diverse research areas The University of Kansas Medical Center (KUMC) and The University of Kansas Health System (TUKHS) serves. They will partner with industry stakeholders to establish streamlined study onboarding processes and compliant conduct of clinical trials. Will manage deliverables to multi-disciplinary teams; oversee project agreements; and nurture external partnerships as well as oversee daily operations of site development staff and project management staff.

Job Description:

Key Roles and Responsibilities:

• Establish and foster strong relationships and business strategies with KUMC study teams, the KUMC Research Administration, and study sponsors.
• Assist with completing site feasibility questionnaires for clinical trials presented to the University of Kansas Medical Center.
• Manage the recruitment toolkit, liaise between KUMC research teams, UKHS, Communications, Research Administration, and provide recruitment information, guidance
• Partner with KUMC Research Leadership and KUMC Affiliates to establish a study feasibility process for clinical trial startups.
• Understand and act within the framework of regulatory guidelines provided by federal, state, and local regulatory agencies and ethical guidelines pertaining to the conduct of clinical research.
• Develop guidance and templates related to study feasibility assessment, ancillary department review process, and clinical trial acuity assessments.
• In partnership with study teams, TUKHS, research support units, and Research Administration, establish and support an institutional feasibility process and resources.
• Act as a liaison between study sponsors, KUMC study teams, and the KUMC Research Administration by evaluating problems and providing solutions.
• Promote a positive work environment that is maintained through open and effective communication.

Required Qualifications

Education:

• Bachelor\'s degree or an equivalent combination of education and relevant life science work experience on a year for year basis.

Work Experience:

• Experience in a medical, laboratory, and/or clinical trial environment to create a thorough understanding of medical, laboratory, and clinical trial concepts and terminology.
• Experience utilizing Microsoft Office and data entry systems.

Preferred Qualifications

Work Experience:

• Previous working knowledge and experience with pharmaceutical sponsors and contract research organizations.
• At least two years of clinical research experience.
• Experience utilizing Epic and CRIS/Velos systems.

Skills:

• Knowledge of FDA regulations relevant to drugs, devices, and biologics.
• Attention to detail with excellent analytical and problem-solving skills.
• Ability to manage multiple tasks and set priorities and meet deadlines.
• Work within a team approach and be motivated to work consistently in a fast-paced, \"customer-focused\" environment.
• Excellent organization l and communication skills.
• Skilled in Microsoft Office and data entry systems.

This job description is not designed to cover or 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 responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Documents:

• Resume/CV
• Cover Letter

Comprehensive Benefits Package:

Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is avail