Required Qualifications:BA/BS in a health related field plus 2 years of work experience in clinical research or a combination of related education and work experience in clinical research totaling 6 yearsAbility to work independently, make decisions, problem solve, mainta prioritize the simultaneous management of multiple clinical studies.Ability to follow strict protocols with the utmost ethical standardsKnowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Code of Federal Regulations (CFR) and Good Clinical Practices (GCP) StandardsComputer proficiency and ability to navigate multiple software applications; experience with computerized data managementDemonstrated accurate data management skills, such as data collection, data entry and quality controlExcellent written, verbal and interpersonal skillsOn-site work 5 days per weekAdditional 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:Experience with business & industry trialsFamiliarity with the research policies and procedures at the University of Minnesota, University of Minnesota Medical Center, Fairview Hospitals and ClinicsExperience with EPIC or other electronic medical records systemsProven detail-oriented with exceptional organizational, planning and problem-solving skills and ability to meet deadlinesCertification as a Clinical Research Coordinator, or qualified to sit for the for the certification examPhlebotomy experienceCoordinate Clinical Research Studies & Participants (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 formance and documentation of clinical research activities.Complete and maintaulatory, 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 ilitating 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.Obtaluding 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 concernsCommunicate 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.Effectively 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 completesource 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 suppliesand equipment, proactively ordering new as well as disposing of expired/unused items when needed, maintaining organization of items.Prepare for, schedule, and participate e initiation visits, monitoring visits, program audits, etc. by coordinating the visits and schedules, leading facility tours, and ensuring requested information is provided.erpret study protocols and inform the development of consent forms and other materials needed for each clinical research study.Maintah as: enrollment logs; participant visit logs; protocol deviation logs; etcThe University of Minnesota, Twin Cities (UMTC)The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities ering 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 Forbes as a Best Employer for Company Culture (2026), Best Employer for Women (2023), and Best Employer by State (2022-2026). In 2026, we also received Culture Excellence & Industry Awards recognition for employee appreciation and work-life flexibility.About the 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.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. 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.
9 days ago