Career Center

The School of Public Health is committed to anti-racism and anti-oppression in our mission and operations. In pursuit of this goal, we consider an applicant’s record working with individuals from historically marginalized backgrounds, and experience identifying and eliminating systemic barriers to success in an academic environment. SPH seeks to increase the diversity of its workforce, we particularly encourage applications from those who belong to groups that have been historically underrepresented in our discipline, including those who are Black, Indigenous, and people of color, those with disabilities, and those from LGBTQIA+ communities.

The Coordinating Centers for Biometric Research (CCBR) in the Division of Biostatistics, School of Public Health at the University of Minnesota conducts international trials of infectious diseases.  Most of these trials are conducted by INSIGHT, an international clinical trials network for which we are the Statistical and Data Management Center (SDMC).  Over the past 2 years, INSIGHT has conducted 8 randomized trials of treatments for patients hospitalized with COVID-19; prior to COVID-19, trials for the treatment of HIV and influenza, and the prevention and treatment of Ebola virus disease were conducted.  Trials are funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

The protocol manager will work as part of a team at the CCBR on clinical trials.  The teams include biostatisticians, data management staff, study drug management staff, regulatory/safety staff, and administrative staff.  They also will work closely with clinical researchers around the world, including investigators at the National Institutes of Health.  

At any given time during the planning and conduct of a trial, tasks performed will vary. Usually, protocol managers will work on a study from its development until it is complete, and results have been disseminated. Tasks for a new trial include:

• Collaboration on data collection plans, including case-report forms (CRFs)
• Drafting procedure manuals and other protocol materials
• Training sites on study protocols and procedures
• Defining edit checks for CRFs.
• Participation on calls and in meetings to write protocols

Tasks for ongoing and completed studies include:

• Serves as point of contact at the SDMC for questions from international coordinating centers who coordinate the work of clinical sites.  Typical questions are related to site registration, study drug shipments, protocol procedures, and CRF completion,
• Preparation of responses to frequently asked questions aimed at improving study conduct
• Recommend changes in procedures and/or CRFs in response to amendments or to correct deficiencies.
• Ensure appropriates web reports are regularly updated and alerting ICCs to deficiencies by sites.
• Work closely with biostatisticians, data management, and regulatory staff to ensure high quality data are collected in a timely manner
• Collaborate on manuscripts and scientific presentations. 

50% Time -- Collaboration with international coordinating centers, monitoring data collection, participation on calls and training

25% Time – Protocol-related activities, such as collaboration on of data collection plans, protocols, procedure manuals and case report forms

25% Time – Collaboration on manuscripts and presentations for conferences and publications

We are looking for a candidate who is interested in global health and infectious diseases, the design and conduct of clinical trials, and working in a collaborative, dynamic and fast-paced environment.

Required Qualifications

• A Master’s degree in nursing or a health-related field
• Documented communication skills
• Ability to manage and track multiple requests and projects simultaneously
• Project management experience

Preferred Qualifications

• Statistical programming experience
• Demonstrated quantitative ability
• Clinical trials and/or epidemiological study experience