Regulatory Coordinator II

UNMC is an Equal Employment Opportunity Employer, including an equal opportunity employer of protected veterans and individuals with disabilities. Location Location Omaha, NE Requisition Number: Requisition Number: Staff_15066 Department Business Unit Business Unit Eppley Institute Reg-Temp Reg-Temp Full-Time Regular Work Schedule Work Schedule Weekdays and weekends; Hours may vary Remote/Telecommuting Remote/Telecommuting Hybrid (part-time working on site, part-time working off-site) Position Summary This position is responsible for oversight of all regulatory documents for complex studies currently in the CTO . Responsible for knowing the IRB and committee requirements and keeping us in compliance with all updates, etc. This person is also responsible for communicating with the appropriate individuals to assure timeliness and efficiency. This position will expand on the Regulatory Coordinator I position. It will focus on higher complexity clinical trials, such as Phase I, transplant, CAR -T, and investigator-initiated trials, and an increasing workload/volume of studies. Initial application review will begin on the date provided in the field above. Applications received prior to this review date will be considered. Applications received after the review date may be considered. Required and Preferred Qualifications Required Education: Required Education: Bachelor's degree or equivalent If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major) Business Administration, Healthcare, Scientific or related field (Will consider seven years related education/experience) Required Experience Required Experience 3 years If any experience is required, please specify what kind of experience: Experience in healthcare, science or clinical research administration (Will consider seven years related education/experience) Required License Required License No If yes, what is the required licensure/certification? Required Computer Applications: Required Computer Applications: Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook Required Other Computer Applications: Required Additional Knowledge, Skills and Abilities: Strong organizational skills required to manage your time and work independently. Ability to work efficiently under deadlines. Independent problem-solving skills. Effective verbal and written communication skills to be able to write reports, contribute to publications and professional presentations. Preferred Education: If any degree/training is preferred, please specify the type: Business Administration, Healthcare, Scientific, or related field Preferred Experience: Work in clinical research to include regulatory submission. Medical terminology exposure in another clinical setting. Preferred License: Preferred License: No If yes, what is the preferred licensure/certification?: Preferred Computer Applications: Preferred Other Computer Applications: Preferred Other Computer Applications: RSS, Clinical Trial Management System Preferred Additional Knowledge, Skills and Abilities: Required fields are indicated with an asterisk (*). * Do you have a high school education or equivalent? Yes No * Do you have experience in healthcare, science or clinical research administration? Yes No

• If you do have experience in healthcare, science or clinical research administration, please elaborate (If No, indicate NA). (Open Ended Question)
• Are you proficient in Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook? Yes

No * How did you hear about this position? Careerlink Employee Referral HERC Indeed Job Fair Lincoln Journal Star Linkedin Omaha World Herald UNMC Job Site Facebook NEWorks Handshake Other

• If Other, please specify the source. Otherwise, indicate NA. (Open Ended Question)
• Within the past 6 months, have you been affected by a reduction in force or grant funding expiration with the University of Nebraska Medical Center? Yes

No Individuals who need accommodation during the online application or interview process may contact View phone number on click.appcast.io or View email address on click.appcast.io to request an accommodation. #J-18808-Ljbffr University Of Nebraska Medical Center