ARDL Research Project Manager

About the role

The Advanced Research and Diagnostic Laboratory (ARDL) is a highly complex research laboratory specializing 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 of patients with diabetes, renal disease, Alzheimer’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 support ongoing biomarker development in all these studies. A unique aspect of ARDL is that it is a clinical research testing laboratory 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 genomics, transcriptomics, proteomics, and functional approaches. Technologies include mass spectrometry for accurate quantitation of molecules, targeted multiplexed assays, DNA/RNA extraction platforms, quantitative real-time PCR, targeted genotyping, next-generation sequencing, immunoassays (ELISAs to targeted multiplexed immunoassays on the Ella platform), proteomic discovery platforms such as Olink, ultra-sensitive protein quantitation on the Alamar NULISA platform, multi-parameter flow cytometry, and a well-established cell culture facility specializing in cell cryopreservation, EBV-based cell transformation, culture of iPSCs, and cell differentiation protocols.

ARDL Project Managers are responsible for managing and serving as knowledge experts in all study performance aspects of large, complex, clinical research trials within a nationally-recognized, NIH-funded Central Laboratory. They support 10-12 UMN Principal Investigators (PIs), develop up to 20+ sponsored and external sales projects per year, and manage the ongoing progress of up to 10-20 projects per manager annually. 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 UMN PI, the manager serves as a representative of UMN and the Central Laboratory at in-person and online steering committee meetings.

Responsibilities

• Pre Award and Financial – 35%
  • Evaluate requests and prepare/submit grant proposals for federal research (sponsored project) funding (NIH) and other Request for Proposal (RFP) packages.
  • Develop, negotiate, and submit budgets accounting for personnel salary, fringe, equipment, supplies, travel, inventory management, and test costs.
  • Meet NIH and sponsor deadlines for grant proposal submissions; submit proposals to UMN Sponsored Projects Administration (SPA) and address questions.
  • Prepare revised budgets based on funding cuts, carry-forward budgets, and no-cost extension budgets.
  • Monitor financial awards (NOGA) against services performed to forecast budget surplus or prevent overruns.
  • Generate revenue by creating/maintaining relationships to establish repeat customers for additional proposals.
• Communication – 25%
  • Collaborate with Principal Investigators, researchers, managers, and administrators during all study phases.
  • Work 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 in conference calls with external clients and represent UMN at steering committee meetings (may include domestic travel).
  • Participate in internal leadership meetings and conduct small group meetings with staff.
• Planning and Oversight (Project Management) – 25%
  • Plan logistics for all study phases, including biospecimen collection, processing, transport, laboratory testing, biorepository, and data management.
  • Monitor performance at clinical sites (may include 100+ sites).
  • Collaborate with ARDL PI to create/implement laboratory workflows to meet turnaround times and project deadlines.
  • Monitor accurate testing and quality assurance; use problem-solving skills to address unexpected issues.
• Write Reports and Manuals – 10%
  • 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, and Letters to sponsors.
  • Prepare IRB submissions and renewals; assist PI on manuscripts for publication or serve 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 software (PowerPoint, Zoom) for development and presentation of training sessions for outside study clients.
  • Participate on study subcommittees and present data on quality assurance and laboratory performance.
  • Train internal laboratory staff on study-specific procedures.

Requirements

• BA/BS in a science-related field with six years of experience or an advanced degree in a science-related field with four years of experience.
• Strong leadership, organizational, communication, and personnel management skills with the ability to train and direct professional and support staff.
• Ability to represent the study and the University professionally.
• Proficient with Microsoft Office suite, Google suite, and Zoom.
• Ability to collaborate and communicate with stakeholders including principal investigators, researchers, managers, and field center staff.
• Ability to work independently, make decisions, problem-solve, and prioritize simultaneous management of multiple clinical studies.
• Highly organized to ensure smooth study implementation and progression.
• Able to provide oversight for grant proposals and budgets; fiscally responsible in this revenue-generating position.
• Capable of working in a laboratory environment with exposure to blood and body fluids.

Preferred Qualifications

• Medical Laboratory Scientist certification – MLS (ASCP).
• Understanding of clinical trials and the research process.
• Experience with research database software including REDCap, Oncore, and Epic.
• Experience with project management software such as Jira, MS Project, or Confluence.
• Experience with IRB submissions.
• Experience in writing grant applications.

Pay

Pay Range: $80,000 - $87,000 annually, depending on education, qualifications, and experience.

Benefits

• 100% time appointment; faculty and P&A staff position.
• Comprehensive benefits package including:
  • Competitive wages, paid holidays, and generous time off.
  • Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program.
  • Low-cost medical, dental, and pharmacy plans; healthcare and dependent care flexible spending accounts; University HSA contributions.
  • Disability and employer-paid life insurance.
  • Employee wellbeing program.
  • Excellent retirement plans with employer contribution.
  • Public Service Loan Forgiveness (PSLF) opportunity.
  • Financial counseling services.
  • Employee Assistance Program with eight sessions of counseling at no cost.
  • Employee Transit Pass with free or reduced rates in the Twin Cities metro area.