This position assists in the management and coordination of research programs and projects for faculty from the Orthopedic Surgery Department at the University of Minnesota. Below is a breakdown of this position’s major responsibilities, other duties may be assigned as needed.
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 (Spine Research Group) - 10% of time:
Attend Spine Research Group meetings.
Track new and active studies.
Track manuscript submissions and acceptances
Track abstract submissions and acceptances for conferences
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
*Required Qualifications (must be mentioned on application/resume):
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
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
Internal Number: 335140
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.