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 seeks a 100% time Regulatory Coordinator to join their clinical research study team.  This full-time position will support the study team in regulatory compliance areas, manage the tracking and submission of regulatory documents related to investigational drugs, conducting clinical site protocol registration activities, and assisting the Project Manager in developing processes and procedures for regulatory compliance for investigational drugs.

The CCBR conducts international trials of infectious diseases. Most of these trials are conducted by INSIGHT, an international clinical trials network for which the CCBR is 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.  For many trials, the CCBR coordinates the regulatory activities related to conducting research on an investigation new drug in an international setting.  Trials are funded by the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH).

Essential Functions or Job Duties

Study Regulatory Documents (30%)

• Assist Project Manager in obtaining, organizing, and maintaining investigational drug-related regulatory documents
• Assist Project Manager in distributing files to the international coordinating centers
• Work with Web Master to post regulatory documents to the INSIGHT website and assure documents are available to all stakeholders
• Write and maintain procedures related to file organization and distribution of investigational drug documents

Protocol Registration (40%)

• Assist Project Manager and collaborate with REDCap developer to create/update protocol registration database for each new investigational drug
• Collaborate with pharmaceutical companies, NIAID, contracted drug distributor, and SDMC staff to develop labels for investigational drug
• Collaborate with REDCap developer and SDMC staff to create, maintain, and improve projects related to investigational drug labeling requirements
• Assist other SDMC staff in developing and distributing additional study-supplied documents requiring IRB/EC approval
• Review regulatory submission and approval documents
• Assist Project Manager in developing procedures to document disposition of remaining investigational drug at end of study
• Write and maintain protocol registration procedures related to investigational drug

Study Drug Distribution (20%)

• Submit regulatory documents required for QP release of investigational drug to pharmaceutical companies and/or contracted drug distributor
• Track QP release and provide regular updates to the study team
• Assist Project Manager in developing procedures to document disposition of remaining investigational drug at end of study
• Assist other SDMC staff with domestic and international drug orders

Other Duties as Assigned (10%)

All required qualifications must be documented on application materials. 

Required Qualifications

• Master’s degree and 2 years of related experience or BS/BA and 4 years of related experience or a combination of related education and work experience to equal eight years
• Demonstrated excellent written and spoken communication skills
• Excellent organizational skills
• Demonstrated capability for self-directed work that may have rapidly-changing requirements and/or priorities
• Ability to manage multiple priorities in a deadline-driven environment
• Comfortable using web-based applications/technology

Preferred Qualifications

• Experience with investigational drug randomized trials
• Familiarity with US clinical trial regulations and/or international clinical trials regulations
• Knowledge of international investigational drug labeling requirements, such as Annex VI