All required qualifications must be documented on application materials.
 

• Qualifications 
  Required: 
  â¢BA/BA in a science related field with six years of experience or an advanced degree in a science related field with four years of experience
  â¢Strong leadership, organizational, communication, and personnel management skills with the ability to train and direct professional and support staff. Must be able to represent the study and the University in a positive and professional way. 
  â¢Proficient with Microsoft Office suite, Google suite, and Zoom
  â¢Ability to collaborate and communicate with the entire spectrum of study participants and stakeholders including principal investigators, researchers, managers and field centers. 
  â¢Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.
  â¢Must be able to document all phases of the process and be highly organized to ensure smooth study implementation and progression. Able to provide oversight for grant proposals and budgets. Must be fiscally responsible in this revenue generating position. 
  â¢Capable of being in a laboratory and exposed to blood and body fluid.

Preferred: 

•  Medical Laboratory Scientist certification
• Understanding of clinical trials and the research process
• Experience with research database software including REDCap, Oncore and Epic
• Experience with IRBs
• Experience in writing grant applications
   

Summary:
The Advanced Research and Diagnostic Laboratory (ARDL) is a highly complex research laboratory that specializes in support of large multicenter clinical trials and epidemiological studies. Specific areas of interest for faculty at ARDL include identification of novel biomarkers of healthy aging and biomarkers for early detection and monitoring or of patients with diabetes, renal disease, Alzheimerâ™s disease related dementias and cardiovascular disease.   Laboratory support for these multi-center studies ranges from novel biomarker development, implementation of standardized biomarker measurement, and coordinating biospecimen collection and processing. ARDL maintains a large central biorepository of 3-4 million aliquots that supports ongoing biomarker development in all these studies. A unique aspect of the ARDL is that it is a research laboratory that is fully accredited by CLIA/CAP and part of the University of Minnesota Laboratory Medicine and Pathology Department under the Medical School.  ARDL supports a wide variety of biomarker platforms spanning the range from genomics, transcriptomics, proteomics to functional approaches. ARDL also utilizes mass spectrometry for accurate quantitation of molecules and targeted multiplexed assays using this platform. Genomics technologies used include a variety of DNA/RNA extraction platforms, quantitative real time PCR, targeted genotyping and next generation sequencing. ARDL performs a wide range of immunoassays ranging from standard ELISAs to targeted multiplexed immunoassays on the Ella platform. ARDL also utilizes proteomic discovery platforms such as Olink and performs ultra-sensitive protein quantitation on the Quanterix platform. In addition, ARDL also performs multi-parameter flow cytometry and has a well established cell culture facility that specializes in cell cryopreservation, EBV based cell transformation, culture of iPSCs and actively developing cell differentiation protocols. 

The ARDL project managers are responsible for managing and serving as knowledge experts in all study performance aspects in large, complex, clinical research trials within a nationally-recognized, NIH-funded Central Laboratory.

Project managers support 10 - 12 UMN Principal Investigators (PIs), develop up to 30+ sponsored and external sales projects per year per coordinator (or manager), all while managing the ongoing progress of up to 20-30 projects per manager per year. 

The project managers function as a liaison between the Central Laboratory and sponsor/study leadership, to plan logistics and coordinate activities throughout all phases of the study or project.  Along with the PI, the manager serves as a representative of UMN and the Central Laboratory at in-person and online steering committee meetings, communicating essential information for successful completion of the study or project. 

Responsibilities:

• Pre Award and Financial-35%
  •  Evaluate requests and prepare and submit grant proposals for federal research (sponsored project) funding (NIH) and other Request for Proposal (RFP) packages. 
  • Develop, negotiate, and submit budgets that coincide with the grant proposals, accounting for all aspects of project scope in budget preparation, including personnel salary, fringe, equipment, supplies, travel, inventory management and test costs.
  • Meet NIH and sponsor deadlines for grant proposal submissions. 
  • Submit proposals to SPA and work with SPA to answer questions regarding the proposal. 
  • Prepare revised budgets based on funding cuts, carry-forward budgets, no-cost extension budgets.
  • Monitor the financial award (NOGA) against the services performed to forecast budget surplus or prevent budget overruns.
  • Generate revenue:  create and maintain relationships to establish repeat customers for submission of additional proposals to generate work/income for the department.budget  surplus or prevent     budget overruns.
• Communication-25%
  • Collaborate with Principal Investigators, researchers, managers, and administrators during all phases of the study.  
  • Collaborate with sponsors and data coordinating centers to investigate issues and improve processes. 
  • Advise clinical sites on study specific protocols and help resolve issues. 
  • Serve as a knowledge expert to outside clients and internal staff.
  • Participate on conference calls with external clients. 
  • Serve as a representative of UMN at steering committee meetings.
  • Participate in internal leadership meetings and conduct small group meetings with staff.
• Planning and oversight (project management)-25%
  • Plan logistics throughout all phases of the study, including set up and implementation of processes related to biospecimen collection, processing and transport; laboratory testing; biorepository and data management. 
  • Monitor performance at clinical sites (may include 100+ sites).
  •  Create and implement a laboratory work flow to meet expected turn around times and project deadlines.  
  • Monitor accurate testing and quality assurance.
  • Use resources and problem solving skills to implement solutions to unexpected issues.
• 10% Write Reports and Manuals- 
  • Develop and write study-specific Laboratory Manual of Procedures (MOP) to harmonize processes across clinical sites. 
  • Develop, analyze and monitor Quality Control Reports (statistical analysis of analytes and performance metrics).
  • Write Progress Reports, Carry-Forward Reports, Letters to sponsors. 
  • Prepare IRB submissions and renewals. 
  • Assist PI on preparing manuscripts for publication or serve independently as co-author.  
• Presenter/Trainer-5%
  • Prepare and present training materials at clinical trial central training sessions (in-person and online).
  • Train field center employees on biospecimen collection.
  • Use appropriate software (Powerpoint, Zoom, etc.) for development and presentation of training sessions for outside study clients.
  • Participate on study subcommittees and present data on quality assurance and other aspects of laboratory performance.
  • Train internal laboratory staff on study-specific procedures.