Clinical Research Regulatory Specialist

2 weeks ago

Madison, Wisconsin, United States University of Wisconsin Full time

Position Overview:
The Clinical Research Regulatory Specialist plays a pivotal role in providing extensive support for clinical investigations within the Department of Family Medicine and Community Health at the University of Wisconsin. This role necessitates close collaboration with both the Health Sciences Institutional Review Board (HS-IRB) and the Health Sciences Minimal Risk Institutional Review Board (MR-IRB). The position is under the supervision of the Director of Research Operations.

Key Responsibilities:
This role is tasked with translating intricate scientific protocols into clear, precise, and accurate clinical research applications, consent documents, and communications. A critical aspect of this position is the ability to manage multiple detailed projects concurrently, ensuring timely completion and adherence to strict deadlines imposed by review committees, boards, and clinical research sponsors.

  • 15% Develop and submit protocol-specific application materials to regulatory entities such as the Institutional Review Board and scientific review committees.
  • 15% Create clear and precise informed consent documents.
  • 20% Act as the regulatory liaison for research studies involving human subjects.
  • 15% Maintain comprehensive and accurate regulatory files and documentation.
  • 5% Engage directly with protocol sponsors regarding regulatory documentation and activities.
  • 15% Provide guidance to research teams on compliance with policies, procedures, and regulations.
  • 5% Conduct quality assurance checks.
  • 5% Potentially lead and mentor other staff members.
  • 5% Contribute to the formulation of new processes, procedures, tools, and training for the team.
Diversity Commitment:
The University of Wisconsin-Madison is dedicated to fostering a diverse and inclusive environment. We recognize that diversity enhances creativity and innovation and are committed to integrating excellence in teaching, research, outreach, and diversity as interconnected goals.

Qualifications:
Required:
- Experience with Institutional Review Board (IRB) submissions or similar processes.
- Strong written and verbal communication skills with faculty, research coordinators, sponsors, and staff at all levels.
- Independent problem-solving and analytical capabilities.
- Ability to juggle multiple projects simultaneously.
- Proven attention to detail and effective time management skills, with experience in accurate and timely documentation.

Preferred:
- Familiarity with relevant software systems and web-based applications, including proficiency in Microsoft Office Suite and experience with Application Review for Research Oversight at Wisconsin (ARROW).
- Background in human subjects research, grants, scientific writing, healthcare, or an academic environment.
- Knowledge of federal regulations regarding human subjects protection.
- Previous experience obtaining Center for Medicare and Medicaid Services (CMS) approval for research initiatives.
- Comprehensive understanding of University of Wisconsin administrative policies and applicable state and federal regulations.

Work Type:
Full or Part Time: 75% - 100%

Additional Information:
This position may require some in-person work at a designated campus location, with the possibility of remote work as well.

Application Process:
To apply for this position, candidates will be prompted to upload a current resume/CV and a cover letter outlining their qualifications and experience.

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