Research Coordinator (Research Professional 3) Department of Orthopedic Surgery

Duties/Responsibilities

Study Participant Recruitment and Management - 60%

• Enroll appropriate participants into clinical trials with regards to the established protocol, Good Clinical Practice, and University of Minnesota and Clinical Partner 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
• Responsible for knowing protocol details, ensuring that protocol is followed, documenting study activities appropriately, and resolving issues that arise during day-to-day implementation of studies.

Study Regulatory Management - 30%

• 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.
• Manage and maintain a regulatory/essential documents binder for each study from initial submission to study closure.
• Assure compliance with all regulations and sponsor stipulations as necessary
• Manage and maintain accurate list and status of research activities within area of responsibility

Protocol Development, Implementation, and Execution- 5%

• Support protocol development for research initiatives
• Write and edit research and technical materials including IRB applications, protocols, consent forms, grant applications, research manuscripts, presentations, abstracts, website content, and user guides.
• Operationalize research protocols for multiple projects, including social/behavioral NIH-funded trials and industry sponsored clinical trials.

Independent Projects- 5%

• Mentor and train junior research staff.
• Manage additional workload and trials during staffing changes.
• Provide process improvement and CRC perspective for work flow improvement.
• Contribute towards departmental goals and strategy
• Complete special projects as assigned.

Required Qualifications (must be listed on resume):

• 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.
• Experience with IRB submissions and IRB reporting requirements
• Experience recruiting, consenting and enrolling patients in clinical research studies.
• Experience with tracking patient enrollment, completing source documents and case report forms.
• 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.
• 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:

• Strong working knowledge and experience navigating EPIC
• Experience setting up projects and using OnCore CTMS
• Familiarity with ETHOS
• Academic clinical research experience
• Familiarity with Orthopedics, and willingness to learn.
• Skilled in the effective, efficient and safe use of equipment.
• Strongly preferred ACRP or SOCRA certification (CCRC, CCRP, or CCRA)

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

About the Medical School:

Committed to innovation and diversity, the Medical School educates physicians, scientists, and health professionals; generates knowledge and treatments; and cares for patients and communities with compassion and respect. We value excellence, inclusiveness, collaboration, and discovery.

The mission of the regional campus located in Duluth is to be a national leader in improving healthcare access and outcomes in rural Minnesota and American Indian/Alaska Native (AI/AN) communities. In partnership with CentraCare, the regional campus in St. Cloud offers a wide range of patient experiences throughout students' education in Greater Minnesota and prepares them to become exceptional clinicians and leaders for rural and immigrant populations

Founded in 1888, the University of Minnesota Medical School has three campuses. A four-year MD program and the MD/PhD program are located on the Twin Cities campus in addition to MD programs at regional campuses in Duluth and St. Cloud.

Pay Range: $30.77-$33.65; depending on education/qualifications/experience

Time Appointment: 75%-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).