The Process Manager, Translational Research supports the Cancer Research Translational Initiative (CRTI) leadership at the Masonic Cancer Center (MCC) in enhancing translation across Translational Working Groups (TWG) and MCC Programs through process improvement and project management. This role bridges the needs of both therapeutic and non-therapeutic research groups, building robust processes within CRTI to support them effectively.

Job Responsibilities:

Development of Processes to Support Translational Research â“ 55%

• Develop and improve processes for cancer biospecimen management:
  • Create regulatory-compliant processes for cancer biospecimen and data release to MCC investigators and external entities.
  • Enhance biospecimen inventory access for MCC investigators.
  • Develop methods to collect sample/data usage and return on investment metrics from MCC biobanks.
  • Provide support for additional clinical, regulatory and quality related deliverables as assigned.
• Identify and address gaps within translational processes, assisting CRTI leadership in finding solutions.
• Identify the translational needs of non-therapeutic research groups and communicate them to CRTI leadership.
• Serve as the primary contact for non-therapeutic translational cores, addressing resource questions and developing translational processes.
• Collaborate closely with CRTI team members and MCC stakeholders to develop efficient processes within CRTI.

Pre-IND Support â“ 20%

• Play an integral role in pre-IND applications, including assembling submission packets and addressing FDA questions/comments in line with regulatory guidelines.
• Identify the relevant FDA office for the IND product and assist the study team in completing the briefing packet.
• Assemble and submit the pre-IND application in a professional, best-practice format.
• Interpret FDA comments and relay information to protocol writers for the IND application and subsequent amendments.

Research Navigator â“ 15%

• Manage and refine the process for requesting services for both therapeutic and non-therapeutic efforts, connecting investigators to MCC/UMN resources and services.
• Collaborate with MCC Shared-Resource leadership and coordinate Shared Resource Internal Advisory Committee meetings.

Administrative â“ 10%

• Work with CRTI leadership to track and manage translational activities across TWGs and MCC Programs.
• Organize CRTI-sponsored events such as annual faculty training, symposiums, and retreats.
• Track CRTI departmental metrics (DSG, DBUC, Industrial Partnerships, CRTI-management work).
• Collaborate with CRTI leadership to address any opportunities, problems, or gaps in projects that may arise.
• Perform other miscellaneous duties as assigned.

Required Qualifications:

• Requires BA/BS with at least 6 years of experience or advanced degree with 4 years of experience.
• Proven excellence in oral and written communication skills.
• Excellent customer service skills and coordination experience.
• Strong organizational skills.
• Extensive experience with Microsoft Office.
• Ability to prioritize and multitask, managing multiple projects simultaneously and completing tasks accurately and on time.
• Capability to work independently, using creativity and initiative to overcome obstacles.
• Experience collaborating with all levels of an organization; must be a team player.

Preferred Qualifications:

• Advanced degree (preferred) or Masterâ™s degree with an emphasis on clinical sciences.
• Experience in an academic or clinical research setting.
• Regulatory/GCP experience.
• Experience with IND/ITP applications to the FDA.
• Experience with report writing.
• Demonstrated problem-solving abilities.
• Flexibility in a fast-changing environment.

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

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