Regulatory Coordinator II

University Of Nebraska Medical Center; Omaha (NE); Hybrid; USD 60,000 - 85,000; Full time

Job summary

University of Nebraska Medical Center in Omaha, NE seeks a Regulatory Coordinator II to oversee all regulatory documents for complex studies in the CTO, ensuring IRB and committee requirements are met and timelines stay on track.

You'll communicate with investigators and study staff, supporting higher complexity trials such as Phase I or investigator-initiated studies, and help manage increasing workload with attention to accuracy and compliance.

Qualifications

• Bachelor's degree or equivalent
• Business Administration, Healthcare, Scientific or related field
• (Will consider seven years related education/experience)
• Experience in healthcare, science or clinical research administration

Responsibilities

• Oversee regulatory documents for complex studies in the CTO and ensure IRB compliance
• Communicate with investigators and study staff to ensure timely, compliant submissions and updates

Skills

Strong organizational skills

Verbal and written communication

Independent problem-solving

Education

Bachelor's degree or equivalent

Business Administration, Healthcare, Scientific or related field

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Job description

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 402-559-4070 or [e-mail] to request an accommodation.