University of Minnesota - Minneapolis, MN

posted 2 months ago

Full-time - Mid Level
Minneapolis, MN
1,001-5,000 employees
Educational Services

About the position

The Clinical Research Project Manager at the University of Minnesota is responsible for overseeing a portfolio of clinical research studies and managing a team of research staff. This role involves ensuring compliance with regulatory requirements, facilitating study start-up processes, and maintaining effective communication with faculty investigators and research sponsors. The position requires a strong background in clinical research, project management, and the ability to work independently and collaboratively in a dynamic environment.

Responsibilities

  • Facilitate efficient and effective study start-up, including billing designations and budget development.
  • Ensure IRB and other regulatory approvals are secured in a timely manner.
  • Collaborate with clinical partners to establish study logistics and manage investigational products.
  • Serve as the primary contact for faculty investigators and research sponsors, promoting research ethics and quality.
  • Monitor participant recruitment and accrual, ensuring compliance with regulatory management.
  • Coordinate subject visits and ensure protocol requirements are met, including timely data submission.
  • Contribute to the production of research publications or presentations of research data.
  • Direct supervision and mentoring of research support staff, including performance evaluations.

Requirements

  • BA/BS in a related field with five years of relevant experience, or an advanced degree with three years of relevant experience, or a combination totaling nine years.
  • Experience preparing and managing IRB and other regulatory review submissions.
  • Expert knowledge of federal regulations governing human subject research.
  • Strong computer proficiency and experience with electronic document management.
  • Detail-oriented with exceptional organizational, planning, and problem-solving skills.
  • Excellent written, verbal, and interpersonal skills.

Nice-to-haves

  • Masters-level degree in a relevant field.
  • Project management experience.
  • Clinical Research Certification (CCRC or CCRP).

Benefits

  • Competitive salary range of $78,000 - $88,000 per year.
  • Opportunities for professional development and training.
  • Comprehensive research support to faculty investigators.
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