Research Professional 6-Clinical Research

Job Duties/Responsibilities:

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 https://med.umn.edu/ortho.

• 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.
• The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations.
• Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.
  

Pay Range: $90,000 Annually; depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Faculty and P&A Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will have the opportunity to complete an online application for the position and attach a cover letter and resume or CV.

This position will remain open until filled.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).