Research Professional 2 - DOM ROAR Team

University of Minnesota

Full-time - Entry Level

Educational Services

About the position

The Department of Medicine at the University of Minnesota is seeking a Clinical Research Coordinator (CRC) to join the Research Operations and Resources (ROAR) Team. This team is recognized as one of the leading research departments in the United States, comprising 11 divisions and supporting a diverse array of clinical research projects. The CRC will play a pivotal role in coordinating clinical research studies, ensuring compliance with regulatory requirements, institutional guidelines, and sponsor expectations. This position requires a high level of independence and accountability, as the CRC will be responsible for managing various aspects of clinical trials from initiation to closeout, including patient recruitment, data management, and specimen oversight. The CRC will be expected to follow Good Clinical Practice (GCP) guidelines and maintain necessary training for safety and regulatory compliance. Responsibilities will include facilitating study startup activities, recruiting participants, scheduling appointments, obtaining informed consent, and ensuring participant safety throughout the research process. The CRC will also collaborate with principal investigators and clinical staff to ensure smooth implementation of research protocols and will be responsible for maintaining accurate documentation and data integrity. This position offers a hybrid work schedule, requiring a minimum of three days in-person work, with flexible hours that may include early mornings, evenings, and weekends depending on the needs of the studies. The CRC will utilize various University systems for documentation and data management, and will be involved in monitoring study supplies and preparing for site visits and audits. Overall, the CRC will be integral to the success of the clinical research projects within the Department of Medicine.

Responsibilities

• Coordinate clinical research studies and participants from study startup through closeout.
• Follow Good Clinical Practice (GCP) guidelines in the conduct and documentation of clinical research activities.
• Complete and maintain necessary training for safety, regulatory, facility access, and data system access.
• Facilitate study startup activities, including creating source documentation and visit checklists.
• Recruit individuals to participate in research projects and verify subject eligibility.
• Schedule participant visits and communicate necessary instructions and reminders.
• Obtain informed consent and conduct assessments of capacity to consent to research.
• Communicate study details to University faculty/staff and lead training on study protocols.
• Collaborate with principal investigators and clinical providers to ensure smooth implementation of research protocols.
• Collect data and conduct assessments as part of study-specific visits, following protocol guidelines.
• Oversee specimen management for multiple projects, including collection and processing of research specimens.
• Complete source documentation for participant study-related visits and ensure adequate documentation is available.
• Support timely and quality data submission and maintenance of participant research records.
• Document any adverse events and protocol deviations, complying with reporting regulations.
• Use University systems to maintain information for all necessary research documentation.
• Monitor study supplies and equipment, ordering new items as needed and disposing of expired items.
• Prepare for and participate in site selection visits, monitoring visits, and audits.
• Maintain regulatory documents and ensure compliance for each clinical research study.

Requirements

• BA/BS in a health-related field plus 2 years of work experience in clinical research, or a combination of related education and work experience totaling 6 years.
• Ability to work independently, make decisions, problem solve, and prioritize multiple clinical studies.
• Knowledge of clinical research compliance standards, including informed consent and adverse event reporting.
• Computer proficiency and ability to navigate multiple software applications; experience with computerized data management.
• Demonstrated accurate data management skills, including data collection and quality control.
• Excellent written, verbal, and interpersonal skills.
• Ability to work a flexible schedule, including occasional evenings and weekends.
• On-site work 3-5 days per week.

Nice-to-haves

• Experience with business and industry trials.
• Familiarity with research policies and procedures at the University of Minnesota and Fairview Hospitals.
• Experience with EPIC or other electronic medical records systems.
• Proven detail-oriented with exceptional organizational and planning skills.
• Certification as a Clinical Research Coordinator or qualified to sit for the certification exam.

Benefits

• 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.