Research Professional -Clinical Research

Overview

Job

Location:

Twin Cities

Job Family:
Research

Full/Part Time:
Full-Time

Regular/Temporary:
Regular

Job Code: 9792CR

Employee Class:
Acad Prof and Admin

Regulatory (15%):

• Develop, write, and monitor Institutional Review Board (IRB) protocols for research including clinical trials and retrospective studies
• Coordinate staff in ensuring all regulatory requirements are met and documented for clinical trials, including but not limited to IRB and FDA reports/filings, electronic regulatory binders, and study report forms.

Administrative/Financial/Grants (15%):

• Grant writing and funding acquisition related to orthopedic research
• Develop, maintain, and track study budgets and associated documents, including budgets associated with grant submissions and progress reports.
• Maintain liaison and strong working relationships with study financial sponsors, representatives of regulatory bodies, data analytic staff, and University administrators.
• Coordinate high-level or mission-critical aspects of clinical studies.

Clinical/Scientific (65%):

• Develop strategic plan for initiation and execution of clinical trials. This will include funding, regulatory, and recruitment goals, with appreciation of the complex interlock between these.
• Collaborate with investigators, project managers, and other study staff, particularly clinical research coordinators and technicians in executing study activities
• Develop and maintain study standard operating procedures, followed by quality control review of collected data
• Recruit and successfully activate sites for studies, including meeting with site personnel on behalf of the PI.
• Contribute to and draft publication-quality reports of study progress and outcomes. This will include both textual and graphical design, with writing to communicate to audiences across a wide range of education and sophistication.
• Review ongoing study outcomes and monitoring data and recommend changes to study design as needed to achieve scientific goals.
• Manage and analyze data sets, including large data sets
• Learn and maintain awareness of the scientific and clinical literature related to orthopedic surgery, sufficient to develop and describe the scientific rationale underlying study designs.
• Drive grant applications in collaboration with the investigator and department team to set grant preparation milestones, gather letters of support, build budgets, write and proofread applications, and other tasks necessary to reach the point of successful submissions.
• Plans and leads scholarly support for abstracts, presentations, and manuscript development, including editing, revision, and submission until abstract and manuscript acceptance, presentation and publication. Contributions will warrant authorship.

Other (5%):

• Other duties as assigned

Required Qualifications:

• Advanced degree with substantial research and publication record
• At least 4 years of prior experience in a research setting (academic or non-academic setting).
• Demonstrated record of peer-reviewed scientific publications in spine, neurosurgical, orthopedic, or health outcomes journals.
• Demonstrated experience in grant writing and funding acquisition related to spine or orthopedic research.
• Demonstrated experience in clinical trials research, including investigator-initiated and/or industry-sponsored trials, protocol development and refinement, and study startup, regulatory submission, and ongoing trial oversight

Preferred Qualifications:

• Doctoral-level degree
• Prior experience managing and analyzing large clinical datasets
• Expertise in statistical analysis and causal inference, such as multivariable and generalized linear modeling, propensity score-based methods, survival and time-to-event analyses, time-series modeling, and machine learning and decision tree-based approaches
• Proficiency in statistical software such as Stata, R, SAS, and/or SPSS
• Prior experience in guideline development, consensus statements, or society-led research initiatives
• Ability to independently draft full study protocols, including background, objectives, statistical analysis plans, and data safety considerations
• Experience in the management of resources and research projects.
• Experience supporting investigators pursuing extramural funding

To learn more about the Department of Orthopedic Surgery, please visit (Use the "Apply for this Job" box below)..

• About the Medical School:
  Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.
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