This position can be found on the University of Minnesota's employment website https://humanresources.umn.edu/content/find-job and can be found under job code 335140 or by searching 'Clinical Research Coordinator (Research Pro 2)- Dept of Orthopedic Surgery'.
About the Job
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
The University of Minnesota offers a comprehensive benefits package including:
- Competitive wages, paid holidays, vacation and sick leave
- Low cost medical, dental, and pharmacy plans
- Health care and dependent daycare flexible spending accounts
- Excellent retirement plans with employer match
- Disability and employer paid life insurance
- Wellbeing program with reduced insurance premiums
- Tuition reimbursement opportunities covering 75%-100% of eligible tuition
- Student loan forgiveness opportunity
- Opportunities for growth and promotion
- Employee Assistance Program
For more information regarding benefits, please click here.