The Advanced Research and Diagnostic Laboratory (ARDL) Study Coordinator (SC) is responsible for managing all study aspects for large, complex, multi-centered grant funded clinical research trials, and external fee-for-service contracts and agreements. The SC develops, designs, and prepares proposals and external sales contracts and agreements, prepares all budgets and other related documents for multi-million dollar research awards, and acts in a revenue-generating role on behalf of the University often times having percent effort salary applied directly on grants. The SC monitors research funding and contract details, and adheres to strict NIH and FDA mandated rules and deadlines for proposal submissions and reports. The SC prepares and submits IRB applications and related progress and renewal documents as part of all studies and projects. The SC oversee and plans the research project, clinical trial, or study by planning and coordinating activities and coworkers including logistics, laboratory work flow, supplies chain, sample receiving and inventory, quality assurance, and data transfer and statistical analysis. The SC acts as an account manager, creates standard operating policy and procedure specific to each study, and trains others accordingly, which may include travel to sample collection sites or customer locations. The SC maintains effective relationships with all external and internal customers at all times, and serves as a knowledge expert for all things laboratory, including publication support and content for investigator related study manuscripts.
Prepare grant proposals for federal research funding (NIH), support and implement industry protocols (FDA, 510 submissions)- this includes all specific federal mandated forms and budget templates.
Develop, negotiate, and submit budgets that coincide with proposals and contracts.
Develop and maintain accurate project budgets including: personnel salary, fringe, equipment, supplies, travel, inventory management, and test costs.
Prepare revised budgets based on funding cuts, carry-forward budgets, and no-cost extension budgets, customer request.
e. Monitor and reconcile financial award against the services that are performed to forecast budget surplus or prevent budget overruns.
Meet NIH/FDA and external customer deadlines for proposal submissions.
Submit proposals on time and by deadline.
Support business growth by involvement with marketing efforts and solicitation.
Collaborate with all internal and external customers during all phases of the study or project including Principal Investigators, researchers, managers, administrators, technical staff, others as needed.
Collaborate with data coordinating centers to support data accuracy.
Advise clinical sites and industry customers on study specific protocols and help resolve issues.
Serve as a laboratory knowledge expert to internal staff and outside clients.
Participate on conference calls with external clients, researchers, vendors, technical staff.
Participate in internal leadership meetings and conduct small group meetings with staff.
Planning and oversight (project management)-25%
Plan all phases of the study, project, or protocol. May include planning and oversight of numerous clinical and collection sites, multiple company locations. Includes planning, set up, and implementation of processes related to aspects of laboratory testing services such as patient enrollment, sample collection, sample processing, sample transport, laboratory testing, and data management. Direct laboratory work flow such that turnaround times and project deadlines are met. Monitor accurate testing and quality assurance, implement and document corrective action as needed.
Develop and maintain manual of operations, quality reports, progress reports, testing results, and customer protocols.
Management and submission of specific gov and company forms (NIH, FDA, Industry).
IRB submissions and renewals.
The University of Minnesota offers a comprehensive benefits package including:
· Competitive wages, paid holidays, vacation and sick leave
· Low cost medical, dental, and pharmacy plans
· Health care and dependent daycare flexible spending accounts
· Excellent retirement plans with employer match
· Disability and employer paid life insurance
· Wellbeing program with reduced insurance premiums
· Tuition reimbursement opportunities covering 75%-100% of eligible tuition
· Student loan forgiveness opportunity
· Opportunities for growth and promotion
· Employee Assistance Program
For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2020_tcd-cslr-75100-ben-0105-7_cs_final.pdf
All required qualifications must be documented on application materials.
Bachelors degree with a minimum of 5 years laboratory experience or an advanced degree with 3 years of laboratory experience or a combination of education and laboratory experience to equal 9 years.
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.
Ability to collaborate and communicate with the entire spectrum of study participants and stakeholders including principal investigators, researchers, managers and field centers.
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.
Capable of being in a laboratory and exposed to blood and body fluid.
Masters degree or Medical Technology certification. Understanding of clinical trials and the research process.
Internal Number: 337969
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.