Print

This position assists in the study coordination and data management of clinical research studies and projects for faculty in the Orthopedic Surgery Department at the University of Minnesota.  Our department focuses on providing state-of-the-art technologies and advanced treatment for the entire spectrum of orthopedic conditions, ranging from ankle sprains and minor bone fractures, sport medicine, cartilage and joint preservation, to the most complex spine, hip knee, and hand or bone cancer surgeries.  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 time:
  •  Recruit and enroll appropriate participants into clinical trials with regards to the established protocol, Good Clinical Practice and University of Minnesota policies
  • Obtain consent from participants
  • Schedule and coordinate participant study visits, ensuring study protocol procedures are completed and ensure complete source documentation
  • Complete sponsor case report forms (CRFs), coordinate monitoring visits and arrange for lab visits and imaging, as necessary
  • Document and report adverse events (AE/SAE) and facilitate timely review with investigator
  • Timely and accurate completion of all required documentation and data entry
  • Facilitate effective engagement with investigators and clinical team for completion of protocol requirements
  • Support a complex portfolio of clinical research projects 
  • Track study information and visits in CTMS system


Study Regulatory Management – 20% of time:

  •  Prepare and complete IRB (Institutional Review Board) applications, informed consent  templates, continuing review reports and ongoing   regulatory reports in a timely manner
  • Prepare, support 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 in accordance with institutional and regulatory requirements to ensure compliance and audit readiness at any given time
  • Support protocol development for research initiatives
  • Assure compliance with all regulations and sponsor stipulations as necessary
  • Prepare for and participate with site initiation visits, monitoring visits, program audits, etc.
  •  Maintain an accurate list and status of research activities within area

Administration and Education - 10% of time:

  •  Attend, participate and contribute in departmental meetings and program initiatives.
  • Ensure accurate project time tracking
  • Educate University faculty and staff of our regulatory and research obligations to our clinical research activities
  • Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
  •  Facilitate new project development
  •  Support quality improvement initiatives
  • Other duties as assigned

Qualifications

All required qualifications must be documented on application materials

Required Qualifications:

  • BA or BS Degree with at least 2 years of work experience in clinical research; or a combination of relevant education and work experience to equal 6 years.
  • Experience with direct patient contact in a clinical/hospital setting
  • Demonstrated data management skills, such as data collection, data entry and quality control
  • Experience completing case report forms
  • 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
  • Excellent critical thinking, decision making and communication skills
  • Demonstrated ability to work well independently and with a team
  • Demonstrates strong organizational and prioritization skills
  • Microsoft applications Word, Excel, and Access


Preferred Qualifications:

  • Clinical Research Certification (CCRC, CCRP), strongly preferred
  • Certified Medical Assistant, Athletic Trainer or similar clinical experience
  • Prior experience enrolling and following patients in clinical research studies
  • Experience using OnCore or other CTMS
  • Experience using REDCap
  • Experience with surgical and/or orthopedic research, preferred
  • Prior experience navigating EPIC electronic medical record (or similar EMR)
  • Database management experience

About the Department

To learn more about the Department of Surgery please visit: https://med.umn.edu/surgery 

How To Apply

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 This email address is being protected from spambots. You need JavaScript enabled to view it. or call (612) 624-UOHR (8647).

To Apply for this job, click here. Please search by Job Opening ID 344350. If you have any questions or concerns, please contact This email address is being protected from spambots. You need JavaScript enabled to view it.

Diversity

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.

Employment Requirements

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.