Clinical Research Coordinator Department of Orthopedic Surgery

This position is responsible for the 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 - 70% of the time:

• Enroll appropriate participants into clinical trials with regards regard 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 - 20% of the 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
  

Other Responsibilities - 10% of the time:

• Assist with literature searches and reference databases
• Maintain timely and professional reports with the research team, faculty investigators, and department
• Prepare presentations related to research projects and activities
• Correspond with sponsors and collaborators as applicable
• Protect patient confidentiality
• Comply with safety guidelines and safe work practices
• Facilitate and communicate information as necessary pertaining to research activities in the orthopedic department
• Support quality improvement initiatives
• Attend research and professional development trainings as appropriate
• Support special assignments and projects as requested

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
• Excellent critical thinking, decision making and communication skills
• Demonstrates organizational and prioritizing skills
• Microsoft applications Word, Excel
• Database management experience with REDCap, Qualtrics
• Experiencing extracting data from patient medical records using EPIC
• Project management experience in healthcare/academic environments
• An interest in clinical outcomes research and patient care
• Experience in clinical research studies

Preferred Qualifications:

• 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
• Experience with surgical research
• Prior experience in writing of scientific reports

To learn more about the Department of Orthopedic Surgery, please visit med.umn.edu/ortho.

Pay Range: $25.00-28.84; depending on education/qualifications/experience

Time Appointment:100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).