Clinical Research Coordinator (Res Pro1 or 2- Research Coordinator)

Job Class: 8351RC, 8352RC - Research Professional 1 or 2 Research Coordinator - Clinical Interventional/Therapeutic, DOQ
Working Title: Clinical Research Coordinator
Supervisor: Kristin Mathson

DESCRIPTION
The Clinical Research Coordinator position exists to support clinical research trials and projects within the Department of Surgery, Surgery Clinical Trials Office. Projects include observational, data-driven outcomes research, as well as interventional research projects. Responsibilities include: patient recruitment, screening, and consenting; data collection and abstraction from the electronic medical record (EMR); implementation of the study protocol; lab kit preparation and collection; planning and oversight for day-to-day activities related to donor project and donor database; and providing direction/supervision to student employees.

This specific position is intended to support our long-term living kidney donor outcomes project in the Division of Solid Organ Transplantation.

A RP2RC will be expected to have more direct research experience, require less training to get started, work more independently, and be able to manage a larger workload independently.

This hybrid position will primarily work independently with day-to-day activities; and report to a Program Manager within the team. The successful candidate will be expected to be in the office 2-3 days per week during the 6-month probationary period and a minimum of 1 day per week after passing probation. With student supervision, this position is likely to be on-site, in-office more frequently.

JOB DUTIES

1. Patient Screening, Recruitment, and Consent- 20%
* Determine subject eligibility, and maintain compliance with protocol eligibility requirements.
* Recruit potential subjects
* Obtain or confirm subject's consent to participate in research.
* Assess the subject's understanding of the research process, procedures and plan; implement and conduct subject and family education in response to identified needs.

2. Coordinate Participant Activities in Protocol- 30%
* Coordinate the implementation of the IRB approved protocol.
* Maintain accurate and complete study records and supplies.
* Collect and ship specimens for research, laboratory, or clinical testing as required, often in repetitive and concise fashion to maintain integrity across all subject visits.
* Monitor subject responses to protocol defined treatments/interventions, and schedule required visits and tests.
* Evaluate laboratory and other findings to determine the presence of expected and unexpected subject reactions or outcomes
* Assess, troubleshoot, and report problems with data collection or other research processes.
* Under the supervision of the PI, report study/medical/test results for subjects and/or families and report significant findings to the appropriate study staff.
* With appropriate training, perform medical device interrogation, programming, and assessment of participant response

3. Collect & Abstract Data- 25%
* Abstract data from medical records and directly enter it into appropriate Research Database.
* Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers.
* Complete and maintain essential source documentation, regulatory documents, and case-report forms (CRFs)
* Collaborate with donor database manager to review database fields and any requested database edits
* Discuss and request QC reports to be generated by the donor database manager and statisticians
* Respond to queries from statisticians regarding available data

4. Communication and Training- 15%
* Coordinate communication between all individuals involved in the research studies (PI, co-PI, sponsor, monitor, clinical staff, other members of the research team, and student employees)
* Write routine correspondence for research projects including letters, memos, and instructional study forms
* Interact with study monitors, department, University, and clinical staff to successfully carry out study requirements.
* Provide ongoing and timely communication on the progress of the study to relevant parties
* Assist in the training of local staff on the protocol. This includes, but is not limited to: assisting in creation of training materials, delivering education to research and clinical staff, and continually re-educating during the active phase of the active phase of the research project.
* Train and instruct student employees on their assigned duties related to the donor project

5. Student Supervision - 10%
* Independently provides supervision for all Student Employees
* Formal HR responsibility for student employees, including hiring, onboarding/off boarding, training, and day-to-day oversight.
* Conducts and delivers ongoing performance reviews for student employees
* Leads meetings with student employees, including project specific trainings and progress meetings

The employer reserves the right to change or assign other duties to this position.

Required Qualifications for RP1RC:
* BA/BS degree, or a combination of education and relevant work experience to equal at least four years.

Required Qualifications for RP2RC:
* BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years.

Required Qualifications for RP1RC and RP2RC:
* Computer proficiency, and ability to navigate multiple software applications
* Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.
* Possess excellent communication skills; verbal and written.
* Ability to work flexible work hours, including some early mornings, evenings, and weekends and on call as needed for studies. Typical hours will be Monday through Friday, but hours may vary based on study needs, which are based on case times.
* Detail-oriented with exceptional organizational, planning and problem-solving skills
* Ability to work independently, as part of a team, with changing priorities
* Demonstrated ability to independently meet deadlines and prioritize assignments
* Ability to interact with patient, staff, and research collaborators on a professional level

Preferred Qualifications:
* Familiarity with standard medical terminology, research terminology, laboratory environments, basic experimental techniques
* Experience with human subjects research.
* Proven experience with computerized data management.
* Certification: National certification in area of specialty or related area preferred. Clinical Research Certification (CCRC or CCRP)
* Experience with EPIC or comparable EMR system.
* Experience with OnCore clinical management system, utilizing Florence and REDCap EDC.

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.

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

Pay Range: Salary will range between $48,000.00 and $56,000.for a RP1RC. Salary will range between $56,000.00 and $63,000.00 for an RP2RC. All offers will dependent on experience and direct qualifications/experience for posted role.

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).