Career Center

This position assists in the management and coordination of research programs and projects for faculty from the Orthopaedic Surgery Department at the University of Minnesota. This position is for a full-time research coordinator to support spine research. The spine surgery group in the Department of Orthopaedic Surgery is a very productive research group that needs dedicated support to complete current and proposed studies. Below is a breakdown of this position’s major responsibilities, other duties may be assigned as needed.

Job Duties/Responsibilities:
Study Participant Recruitment and Management - 60% of time:

• Enroll appropriate participants into clinical trials with regards to the established protocol, Good Clinical Practice and University of Minnesota policies
• Obtain consent from participants
• Coordinate participant study visits and ensure complete source documentation
• Complete sponsor case report forms (CRFs), coordinate monitoring visits and arrange for lab visits and imaging if necessary
• Complete and manage adverse event (AE), serious adverse event (SAE) and deviation logs per department/sponsor requirements

Study Regulatory Management - 30% of time:

• Prepare and complete IRB (Institutional Review Board) applications, informed consent documents, and data collection forms as well as completing continuing review reports and regulatory reports in a timely manner
• Prepare and complete other regulatory documents, including delegation of authority logs, financial disclosure forms, FDA forms (1572s, etc)
• Maintain a regulatory/essential documents binder for each study
• Support protocol development for research initiatives
• Assure compliance with all regulations and sponsor stipulations as necessary 
• Maintain accurate list and status of research activities within area of responsibility

Program Management - 10% of time:

• Attend Spine Research Group meetings.
• Track new and active studies.
• Assist with grant proposals as well as budgeting and determining pricing for grant.
• Assist with other study-related tasks such as but not limited to preparing, filing or copying study materials for investigators and staff, and/or scheduling meetings
• Assist with managing financial and administrative transactions (e.g., purchase and track participant incentives, order mailing supplies)
• Assist with manuscript preparation and formatting of papers for submission to scientific journals
• Other duties as assigned

All required qualifications must be documented on application materials/

Required Qualifications:

• BA or BS Degree with at least 2 years of work experience in research; or a combination of related educations and work experience to equal 6 years.
• Demonstrated ability to work well independently and with a team
• Demonstrated ability to adhere to Good Clinical Practice (GCP), FDA Regulations, HIPAA, as well as University policies and procedures, particularly relating to human subjects and secure study files
• Experience with direct patient contact
• Excellent critical thinking, decision making and communication skills
• Demonstrates organizational and prioritizing skills
• Microsoft applications Word, Excel, and Access

Preferred Qualifications:

• Experience in clinical research studies
• Experience with surgical research
• Project management experience in healthcare/academic environments
• An interest in clinical outcomes research and patient care
• Prior experience in writing of scientific reports
• Experiencing extracting data from patient medical records
• Database management experience