Clinical Research Project Specialist

About the Job

Job Class
: 8354CP - Research Support Professional 4 -

Working Title: Clinical Research Project Specialist

Supervisor: Mary Farnsworth

Program

Description:

At the University of Minnesota, Department of Surgery, our experts, care teams and researchers are advancing science and patient care. The Surgery Clinical Trials Office (SurgCTO) supports a variety of research projects and portfolios in the Department of Surgery. We serve the University’s research mission by providing comprehensive research support to faculty investigators conducting medical research. We accomplish our mission by
1) developing competent professionals specialized in clinical research,
2) creating effective and efficient pathways for conducting compliant clinical research, and
3) fostering a participant‑centric research culture.

We especially strive to have our community better reflect the broad range of identities in our state, including race, ethnicity, gender identity, gender expression, sexual orientation, language, disability, age, national origin, religious practice, access to health services, and socioeconomic status. Our program seeks to foster an inclusive environment in which members from diverse backgrounds are encouraged to develop their skills of scientific inquiry.

Position Summary:

In close partnership with the SurgCTO leadership team (Clinical Research Operations Director and Program Managers), this position is responsible for the project‑level coordination and operational execution of a portfolio of research studies within assigned Surgical divisions. The Clinical Research Project Specialist serves as a subject matter resource on research implementation and serves as an on‑the‑ground resource for investigators. The Clinical Research Project Specialist supports the efficient use of resources within SurgCTO, University of Minnesota, Fairview, and MHealth resources.

Research Project Lead duties include: assisting with the development of research studies, securing regulatory approvals, partnering with unit leadership on budget development and financial management, monitoring study accrual, and ensuring successful overall study coordination and compliance with applicable regulations and guidelines. The Clinical Research Project Specialist works independently on project tasks of moderate complexity, but receives guidance and direct support/training in complex situations.

This is a project‑focused role without supervisory or team leadership responsibilities. Occasional evenings, weekends, and on‑call duties may be required. There may be times that the nature of this work would require that the employee be considered an 'essential employee.'

This hybrid position will primarily work independently with day‑to‑day activities; and report to the unit Director of Operations. Given the supportive nature of the role, the successful candidate should expect to be in the office at minimum 3 days per week. The ability to work remotely exists and is dependent on work duties.

This position is not eligible for visa sponsorship.

Clinical Trial Portfolio Management and Oversight (50%)

• Support faculty: serve as a resource to faculty and staff conducting research, both ad‑hoc generically and throughout the lifecycle of any given research project
• Serve as the point‑person and provide guidance for investigators on resourcing needs required to advance clinical research and assist investigators with gaining access to respective resources. This includes the identification and coordination of internal and external stakeholders (e.g. biostatistics, recruitment, information, regulatory, finance, data management, study coordination, outside industry sponsors, cooperative groups, University consortiums, etc.)
• Efficiently and effectively participate in study start‑up, which includes:
  • Determining billing designations, informing calendar build, ensuring accurate pricing and budget development; assist the OM, as requested, with budget development and negotiation for industry‑sponsored trials; partner with Surgery Grants and Contracts (SGC) for grants and subawards
  • Ensuring IRB and other regulatory approvals
  • Collaborate…