*Position Filled* Clinical Research Coordinator (Research Pro 2)- Dept of Orthopedic Surgery

The UMN has suspended hiring for most positions. However, we will continue hiring for positions critical to the University's mission and operations at this time. Applications are being accepted for this position and you are encouraged to apply. In-person interviews are suspended indefinitely and will be replaced by interviews in a virtual format. Thank you for your continued interest in working at the University of Minnesota.

Qualifications

Required (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

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

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

To apply for this position please go here and search for Job Opening ID 335140.

https://humanresources.umn.edu/content/find-job

If you have any questions or concerns, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..