Research Professional 2 - DOM ROAR Team

University of Minnesota - Minneapolis, MN

Full-time

Minneapolis, MN

Educational Services

About the position

The Department of Medicine at the University of Minnesota is seeking a Clinical Research Coordinator (CRC) to join its 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 through 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 role also involves collaborating with principal investigators and clinical staff to ensure smooth implementation of research protocols, as well as managing data collection and documentation to maintain audit readiness. 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 responsible for maintaining regulatory documents and ensuring compliance with all research requirements.

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, and data system access.
• Facilitate study startup activities, including creating source documentation and visit checklists.
• Recruit individuals for research projects and verify subject eligibility.
• Schedule participant visits and communicate necessary instructions and reminders.
• Obtain informed consent and assess 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 visits, following protocol guidelines.
• Oversee specimen management for multiple projects, ensuring compliance in collection and processing.
• Complete source documentation for participant visits and ensure adequate records are available.
• Support timely data submission and maintenance of participant research records.
• Document adverse events and protocol deviations, complying with reporting regulations.
• Use University systems to maintain research documentation and monitor study supplies.
• 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 education and experience totaling 6 years.
• Ability to work independently and manage multiple clinical studies simultaneously.
• Knowledge of clinical research compliance standards, including informed consent and adverse event reporting.
• Computer proficiency and 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 required 3-5 days per week.