University of Minnesota - Minneapolis, MN

posted 7 months ago

Full-time - Mid Level
Minneapolis, MN
Educational Services

About the position

The Department of Anesthesiology at the University of Minnesota is seeking a Research Professional 2 to join our dynamic research team. This position is integral to our commitment to supporting the research initiatives of our faculty, both in clinical and basic science domains. The successful candidate will work closely with a team of researchers dedicated to assisting faculty with their clinical projects. We have established a robust internal review and advisory process designed to help faculty refine their research ideas and successfully navigate the journey from concept to completion. Additionally, the role includes comprehensive support for all aspects of the Institutional Review Board (IRB) application process, ensuring compliance and facilitating smooth project execution. In this role, the Research Professional 2 will be responsible for managing subject recruitment and data management, which constitutes a significant portion of the job. This includes serving as a liaison with clinics and offices to facilitate recruitment efforts, organizing and maintaining subject identification, recruitment, enrollment, and retention processes, and ensuring accurate data transmission to the appropriate databases. The candidate will also be tasked with maintaining source documents, prioritizing daily tasks related to anesthesiology protocols, and identifying and assessing adverse events. Reporting adverse events in a timely manner is crucial, as is assisting in the analysis of results and contributing to the development and submission of abstracts and publications. The position also involves regulatory management, where the candidate will support all aspects of human subject protection regulations, complete necessary IRB documentation, and manage all IRB submissions and correspondence in conjunction with the Principal Investigator (PI). The candidate will be responsible for tracking and maintaining regulatory documents and preparing for site initiation visits, monitoring visits, and regulatory audits. Administrative responsibilities include maintaining the departmental research database, publishing updates on study progress, and coordinating site visits and audits. This multifaceted role requires a detail-oriented individual who can manage multiple protocols concurrently while ensuring compliance with regulatory standards and contributing to the overall success of the research initiatives within the Department of Anesthesiology.

Responsibilities

  • Serve as liaison with clinics and offices to facilitate recruitment
  • Organize and maintain subject identification, recruitment, enrollment, and retention, including follow-up calls
  • Obtain data and accurately transmit to appropriate database
  • Maintain source documents
  • Organize, prioritize, and accomplish daily tasks related to anesthesiology protocols
  • Identify and assess adverse events; responsible for subject protocol triage and symptom management; report adverse events in a timely fashion
  • Assist in analysis of results; assist with development and submission of abstracts and publications
  • Act as resource for protocol development, statistical design and budget preparation
  • Translate protocol required activities into flow sheets and patient care orders
  • Support all aspects of human subject protection regulations: complete required IRB regulatory documentation, manage all IRB submissions and correspondence in conjunction with PI
  • Track and maintain all binders and regulatory documents
  • Prepare for and participate in site initiation visits, monitoring visits, regulatory audits, etc.
  • Maintain departmental research database; obtain and publish updates of study progress
  • Coordinate site visits, audits

Requirements

  • BA/BS in health-related field plus 2 years of relevant research experience or a combination of education and research experience totaling 6 years
  • Experience recruiting, consenting, and interacting with human research subjects, proven ability to recruit/retain subjects
  • Experience with paper and computerized clinical case report forms and data collection; experience with research databases and study spreadsheets
  • Knowledge of Good Clinical Practices and federal regulations related to clinical research, including knowledge of adverse event reporting
  • Computer proficiency and ability to navigate multiple software applications
  • Ability to work flexible hours as required to recruit and enroll research subjects
  • Ability to organize and manage several protocols concurrently
  • Ability to prioritize tasks
  • Meticulous attention to detail

Nice-to-haves

  • Experience and proficiency with protocol development, including basic statistical concepts (sample size calculation, alpha and beta error, etc)
  • Experience with research database software including REDCap, Oncore, Epic, and Microsoft Access
  • Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies
  • Experience with IRBs
  • Familiarity with the University of Minnesota Medical Center-Fairview hospital and clinics
  • Experience with anesthesiology and phlebotomy

Benefits

  • Competitive wages
  • Paid holidays
  • Generous time off
  • Continuous learning opportunities through professional training and degree-seeking programs
  • 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)
  • Financial counseling services
  • Employee Assistance Program with eight sessions of counseling at no cost
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