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.

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 (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