Rsch Pro 6-Clinical Research (50%) - IDIM

Job Duties:

Clinical & Scientific Leadership (65%)

• Serve as a Principal Investigator (PI) or Lead Scientist in the development and submission of NIH grants for high-impact international clinical trials.
• Design and oversee the strategic framework for clinical trial initiation and execution. This involves managing the complex interdependency between global funding cycles, international regulatory landscapes, and site-specific recruitment goals.
• Lead and mentor current clinical research coordinators to ensure the seamless
  execution of study activities across global sites.
• Spearhead the recruitment and activation of international research sites, acting as the primary representative for the PI during high-level meetings with site leadership and
  personnel.
• Perform continuous quality control reviews of collected data and monitor study outcomes; proactively recommend and implement modifications to study designs to ensure scientific objectives are met.
• Direct the development of abstracts, presentations, and manuscripts. Oversee the entire lifecycle from initial drafting and revision to final submission and publication, contributing at a level that consistently warrants senior authorship.
• Maintain an expert command of clinical literature regarding infectious diseases to define the scientific rationale for future study designs and innovative research methodologies.

Administrative, Financial & Grants Management (15%)

• Drive the end-to-end grant application process. This includes establishing preparation milestones, securing international letters of support, and synthesizing complex applications for successful federal and private submissions.
• Develop and manage multi-year study budgets and financial documents. Ensure that grant submissions, sub-awards, and progress reports (RPPRs) are meticulously tracked and remain compliant with University and sponsor regulations.
• Build and sustain high-level partnerships with financial sponsors, representatives of global regulatory bodies (FDA, EMA), data analytics teams, and senior University administration.
• Manage the most sensitive or high-risk aspects of clinical studies to ensure the continued progress and integrity of the research portfolio.

Regulatory (20%)

• Author, implement, and monitor Institutional Review Board (IRB) protocols for complex clinical trials and retrospective studies, ensuring ethical standards are maintained across diverse research environments.
• Participate team in meetings and assist with regulatory requirements. Oversee the preparation and filing of critical FDA reports, electronic regulatory binders (eReg), and standardized study report forms.
• Other duties as assigned.
  

Required Qualifications:

• Advanced degree with substantial research and publication record
• MD Clinical researcher
• Expertise in clinical trials for HIV-related meningitis
• Extensive research experience with >100 peer-reviewed publications
• Prior experience in writing NIH grants

Preferred Qualifications:

• Experience with cryptococcal meningitis clinical trials.
• Experience conducting clinical trials in Sub-Saharan Africa

Pay Range: The starting pay range for this role is $40,000 to $53,000 prorated to 50% fte depending on education/qualifications/experience

Time Appointment: This is a 50% fte appointment for 12 months.

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
• Medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and life insurance
• Employee wellbeing program
• Retirement plans
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost

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).