Overview
The Department of Medicine is hiring a Clinical Research Coordinator (CRC) to support clinical research projects conducted by the department's Research Operations and Resources (ROAR) Team. The Department of Medicine is one of the top research departments in the United States and represents the largest research faculty group at the University of Minnesota, comprising 11 divisions. The MED ROAR Team supports a high volume of varied research projects across these divisions.
The CRC would be expected to work independently to coordinate clinical research studies according to regulatory requirements, institutional guidelines, investigator-initiated protocols, and sponsor expectations. Duties are determined by protocol-specific requirements and may include initiating new trials, screening patients for eligibility, coordinating the enrollment of eligible patients, extracting and reporting accurate patient data, managing lab samples/specimens, responding to data queries, and assisting with monitor visits. This position is accountable to physician-investigators and members of the clinical research team.
This position can support a hybrid work schedule with a minimum of 3 days in-person and will vary depending on the research studies assigned. The position has flexible work hours and could include some early mornings, evenings, and weekends as needed for studies.
Job Duties:
Research Study and Participant Management (100%)
* Duties are determined by protocol-specific requirements and will include research activity from study startup through closeout and following participants from beginning to completion of the study.
* Follow Good Clinical Practice (GCP) guidelines in the conduct, performance and documentation of clinical research activities.
* Complete and maintain necessary training for safety, regulatory, facility access, and data system access.
* Facilitate study startup activities following guides and checklists to implement protocols, assess study related needs, create source documentation, visit checklists, and logs or other documents as required.
* Recruit interested individuals to participate in research projects and engage with the study team in verifying subject eligibility, facilitating subject enrollments, and ensuring compliance in the completion of research activities.
* Facilitate the completion of participant visits by scheduling appointments with participants and clinical staff following the protocol, providing necessary instructions, materials and reminders to participants, booking rooms, registering participants, and other tasks as needed.
* Obtain informed consent and assent, including assessments of capacity to consent to research. Obtain re-consent as needed.
* Conscientiously conduct research study activities to protect and promote participant safety, communicating clearly and promptly about any potential concerns
* Communicate information about assigned studies to other University faculty/staff, including details of study, inclusion/exclusion criteria, other enrollment requirements, visit needs, etc., leading training of study staff, clinical, and lab partners on study protocols activities as it relates to their roles on the study.
* Collaborate with the principal investigator/study team and with clinical providers and other departments to ensure smooth implementation and operation of the research protocol and study specific procedures are completed.
* Work independently in multiple locations with hospital and clinic staff to complete research related tasks.
* Collect data and conduct assessments as part of study specific visits, in-person or remotely, following protocol specific guidelines, including data abstraction from medical records.
* Oversee specimen management for multiple projects, including monitoring the collection, processing, and storage or compliant shipment of research specimens to research laboratories, and return of results.
* Correctly and accurately complete source documentation for participant study-related visits along with other required documentation as needed; engage with providers and investigators to ensure adequate source documentation is available.
* Support timely and quality data submission and maintenance of participant research records.
* Complete and ensure appropriate documentation for any adverse-event (AE), serious adverse event (SAE) and protocol deviation, complying with reporting regulations and timelines, and notifying appropriate individuals/entities per research requirements.
* Use University systems such as Florence, OnCore, Box, Smartsheet, and REDCap to maintain information for all necessary research documentation.
* Monitor study supplies and equipment, proactively ordering new as well as disposing of expired/unused items when needed, maintaining organization of items.
* Prepare for, schedule, and participate in pre-site selection visits, site initiation visits, monitoring visits, program audits, etc. by coordinating the visits and schedules, leading facility tours, and ensuring requested information is provided.
* In collaboration with the research team, interpret study protocols and inform the development of consent forms and other materials needed for each clinical research study.
* Maintain regulatory documents, such as: enrollment logs; participant visit logs; protocol deviation logs; personnel training records; recruitment/screening logs; randomization keys; device/account tracking logs; and other documentation as required.
* Support the study team in maintaining regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time.
* Duties may change or other duties may be assigned to meet the needs of the ROAR study portfolio.

Required Qualifications
* BA/BS or a combination of related education and work experience in a clinical or research setting to equal 4 years
* Ability to work independently, make decisions, and problem solve while following strict protocols with the utmost ethical standards
* Computer proficiency and ability to navigate multiple software applications
* Demonstrated ability to maintain deadlines and prioritize the simultaneous management of assignments
* Excellent written, verbal and interpersonal skills
* Ability to work a flexible schedule, including occasional evening and weekends
* On-site work 3-5 days per week
* Additional requirements per Fairview Research Administration may include proof of non-active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis and influenza. Additional background checks will be completed by Fairview Health Services as a condition of employment in this position.
Preferred Qualifications
* Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (CFR) and Good Clinical Practices (GCP) Standards
* Demonstrated data management skills, such as data collection, data entry and quality control
* Detail-oriented with strong organizational, planning and problem-solving skills
* Familiarity with the research policies and procedures at the University of Minnesota, University of Minnesota Medical Center, Fairview Hospitals and Clinics
* Experience with EPIC or other electronic medical records systems

Working at the University

At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work.

The University also 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

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

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.

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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.

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About U of M 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.

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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.