Research - Laboratory/Non-Laboratory, Staff/Administrative
We wish to recruit a dedicated Research Support Manager 2 to lead the clinical research arm of the Microbiota Therapeutics Program (www.microbiota-therapeutics.umn.edu/) and serve as the senior-most research specialist in the Luminal GI Section. Microbiota Therapeutics is an emerging new frontier of medicine, and we have been early leaders in the field. Dr. Alexander Khoruts holds multiple investigative new drugs (INDs) as a sponsor, a principal investigator, or both in this area.
One major goal of the Microbiota Therapeutics Program is to become a central hub for many collaborators within and outside the University for research dealing with Microbiota Therapeutics. Our program will develop and manufacture various formulations of microbiota, and share these resources with other academics. We will also share our expertise with other investigators in all aspects of clinical trial design in this newly emergent area, including assistance in development of regulatory documents. The individual hired for this position will need to function at this high level of expertise, leadership, and engagement.
At this time our program has already matured to a new level that requires a dedicated person to coordinate all the different aspects of this growing enterprise. The multiple challenges for the individual to take on this role include:
1. FDA regulation. This area of microbiota therapeutics is new. It is regulated by the FDA as a drug, biologic, and live biotherapeutic. Regulatory paradigms are still in a period of highly dynamic evolution. The individual in this position needs to have deep experience in developing a variety of clinical protocols for IND submissions. Ideally, she or he is familiar with various regulatory and practical nuances involved specific to the field. The individual will lead development of a Drug Master File and multiple INDs, as well as maintain these with the FDA. The individual will be expected to engage in continued education of all necessary regulatory policies and guidelines through training courses and conferences. 2. Good Manufacturing Process (GMP). The individual should be well versed with GMP protocols, participate in development of standard operating procedures (SOPs), and lead adherence to these by all research personnel. This individual will develop standard operating procedures, write study protocols, create data collection tools, oversee and execute data collection and data analysis. 3. Internal Review Board (IRB) regulation. The individual must have or quickly develop mastery of the University IRB system, as well as all ancillary elements that are required for clinical research – OnCore, HIPCO, Fairview Research, external IRB submissions, etc. He or she is responsible for development and submission of IRB protocols, including review, critique, and construction of experimental design and consent forms. 4. Implementing and maintaining all IRB communication. 5. Supervision of other research staff, including several clinical research associates, community health assistants, student workers, and volunteers. All of whom are part of the research team already. In addition, she or he will assist with supervision of fellows and residents involved in clinical research. 6. Individual projects in the GI Luminal Section are led by different PIs. Currently, these are Drs. Khoruts and Dr. Vaughn. There are also active collaborations involving investigator-initiated INDs within the University and outside institutions. However, we anticipate continued growth. The individuals should be able to critically evaluate emerging collaborations within the University and outside, and assist with development of new clinical trial protocols within these collaborations. 7. The individual should be prepared to function at various levels, seamlessly stepping into the roles of current research staff when there is no immediate alternative. 8. Supervise and maintain secure data management with adherence to privacy principles intrinsic to working with human subjects. These databases will be used in multi-center projects. The individual should be able to develop electronic tools for secure communication and capturing de-identified data from multiple study sites. 9. The research work characteristically involves multiple Co-PIs that bring different technical elements to the projects. This individual will facilitate coordination between all the investigators and ensure efficient collaboration. 10. The individual will be expected to assist with the dissemination of research findings through peer-reviewed publications, reports, conference papers, and presentations. This individual will also help with grant proposals for new microbiota based research studies.
Effort is approximately distributed in the following way:
40% Regulatory work – FDA, IRB, etc.
20% Supervision and instruction of other research staff
10% Interaction with the Manufacturing Team
20% Coordination of work with multiple PIs
10% Dissemination of research findings and fund-raising activities
• Requires an advanced degree with at least 6 years of experience; or a bachelor's degree and 8 years of experience. • A strong understanding and experience with regulatory policies, such as FDA, NIH, and IRB. Must be able to interpret how regulations impact various research projects and apply this to the development of study protocols. Educational background in research policy and biomedical ethics is a plus. • The creation and management of new research programs, providing expert knowledge and consultation to academic faculty and staff. • Ability to solve complex problems with few or no existing practices already in place. Must be able to adapt to evolving policies and regulations, requiring ingenuity with regards to resolving issues. • Must work independently, able to make decisions with minimal guidance from PIs. • Must be able to supervise and work productively with multiple research staff members. • Demonstrated ability to collaborate with multiple PIs and University administrators across academia. • Advanced knowledge of human subjects based research regulations and bioethical guidelines. Familiarity with the IRB process, including the ancillary programs (e.g., OnCore), is required. • Ability to build complex databases to capture human research trial data. • Supervisory experience, along with interviewing and hiring employees.
Internal Number: 333641
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