This position is responsible for the management and coordination of research programs and projects for faculty from the University of Minnesota Department of Orthopedic Surgery. This position is for a full-time research coordinator to support several different sub-specialties within orthopedic surgery. In addition, the role will support department research by managing the Research Committee and helping to coordinate the resident research program. Below is a breakdown of this position’s major responsibilities, other duties may be assigned as needed.
Job Duties/Responsibilities Study Participant Recruitment and Data Management - 50% of time: • Manage all aspects of complex clinical trial participant enrollment and data collection with regards to the established protocol, Good Clinical Practice and University of Minnesota policies • Obtain informed consent from participants • Determine eligibility of potential subjects on assigned studies • Randomize/register eligible subjects to assigned studies • Coordinate participant study visits and ensure complete source documentation • Set up systems for timely data collection to meet requirements of sponsors/monitors • Review U • 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 • Assist with managing financial and administrative transactions (e.g., purchase and track participant incentives, order mailing supplies)
Study Start-up and Regulatory Management - 30% of time: • Project manage all aspects of the clinical trial start up process, including protocol writing, obtaining appropriate regulatory approvals, developing study budgets and ensuring contracts are routed and finalized. • Manage complex, multi-site trials where UMN is the lead site • 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 • Maintain a regulatory/essential documents binder for each study • Assure compliance with all regulations and sponsor stipulations as necessary • Maintain accurate list and status of research activities within area of responsibility • Manage assigned studies through the study life-cycle • Communicate with department faculty and staff regarding protocol requirements • Communicate with other University and hospital department s regarding protocol requirements
Program Management - 20% of time: • Process Improvement Initiatives o Work with Clinical Research Manager and Vice-Chair for Research to identify process improvement areas and lead process improvement initiatives for research operations in the department o Use clinical research expertise to develop Orthopedic Surgery research best practices o Act as lead research coordinator and mentor new research staff • Research Committee program management o Schedule and attend Research Committee meetings. o Review proposals and send to committee members o Lead process improvement efforts with the goal of creating a new system for assigning SMEs to review. o Track and report on finances of RC protocols that have received funding • Resident Research Program Management o Track new and active resident research projects. o Coordinate with Research Manager and Resident Research Director to assist residents in finding appropriate research projects and helping to remove road blocks along the way. o Participate in process improvement/development efforts o Work with Research Manager to education residents on the research process • Assist the research manager and Vice-Chair for Research in developing new processes to make the research process easier for faculty investigators • Assist in ensuring annual workplan is successful • Assist with grant proposals as well as budgeting and determining pricing for grant. • Assist with manuscript preparation and formatting of papers for submission to scientific journals • Other duties as assigned
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 day care flexibile 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 on employee benefits please click here.
Sr. Clinical Research Coordinator (Research Professional 3 [8352P3])
All required qualifications must be documented on application materials. Required Qualifications • Bachelor of Science plus at least 4 years of experience, or advanced degree and 2 years of experience, or a combination of related education and work experience to equal 8 years. • Clinical trial experience. • 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 • Strong interpersonal and communication skills, and ability to work with a diverse community and a diverse set of stakeholders including researchers, clinicians, support staff and patients. • Ability to work independently and prioritize tasks.
Preferred Qualifications • Familiarity with orthopedics, and willingness to learn. • Prior training or certification in the responsible conduct of research. • Skilled with Microsoft Office specifically Excel, PowerPoint, electronic charting programs to conduct chart reviews and data abstraction. • Experience with IRB protocol, patient enrollment and data collection. • Demonstrated excellence in customer service and patient community skills. • Experience interacting with clinic staff and patients to ensure complete and accurate collection of patient-reported outcome measures.
Internal Number: 338078
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.