About the Job
The primary purpose of this position is to support clinical research projects in the Department of Medicine according to regulatory requirements, institutional guidelines, and sponsor expectations.  Duties are determined by protocol-specific requirements and may include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries.  This position reports to the Director of Clinical Research Administration, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.


Job Duties:
During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.

Clinical Research Conduct & Facilitation (85%)
• Coordinate multiple clinical research projects as assigned, following Good Clinical Practice (GCP) guidelines in the conduct, performance and recording of clinical research,
• Facilitate the successful implementation of a protocol, read and interpret clinical protocols, assess needs, evaluate feasibility and provide input to facilitate implementation including completing startup tasks required to activate a stud.
• Coordinate research participant’s recruitment, screening, enrollment, ongoing participation, follow-up, etc. for assigned clinical research projects:
• Recruit potential subjects
• Determine subject eligibility, and maintain compliance with protocol eligibility requirements
• 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
• Perform research procedures for collection of meaningful research data with procedures determined by protocol-specific requirements that may include any research activity from protocol development through study closeout. Responsible for continuity of research subject care and following the subject from beginning to completion of the study
• Collect, and ship specimens for research, laboratory, or clinical testing as required, often in repetitive and concise fashion so as 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
• 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
• Assess, troubleshoot, and report problems with data collection or other research processes
• Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue
• Ensure timely and accurate data submission as well as maintenance of research documentation: collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers/providers and investigators to ensure adequate source documentation is available
• Contribute to the efficiency and effectiveness of the research process by offering suggestions and participating as an active member of the research coordination team.
• Act as a liaison between Investigators, University departments, outside sponsors, clinical partners, collaborators, and affiliates
• Prepare for and participate in site initiation visits, monitoring visits, regulatory audits, etc.
• Act as an information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc.
• Maintain accurate and complete study records, supplies, and time keeping tools.
• Attend national meetings as appropriate

Regulatory (10%)
• Partner with Regulatory Specialist, the PI and the rest of the study team to ensure ethical conduct of clinical trials
• Support the Investigators in ensuring the protection of all human research participants according to Federal regulations, University policies, and sponsor expectations.
• Provide documentation and reports related to subject experience on trials (adverse event reports, subject complaints, etc.) to the research team to ensure compliance with applicable policies, procedures and regulations
• Assist with, review, and track Institutional Review Board (IRB), regulatory, and FDA submissions
• Lead the preparation for and participate in site initiation visits, monitoring visits, program audits, etc. for assigned trials
• Participate in quality control and internal monitoring activities

Education (5%)
• Educate University faculty and staff of our regulatory and research obligations in relation to program research activities
• Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
• Assists in implantation of training of local staff on study protocols.  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
• Contribute to the education of other research coordinators through training new staff, participating in mentoring opportunities, and engagement with the University clinical research community

The University of Minnesota offers a comprehensive benefits package including:
• Competitive wages, paid holidays, vacation and sick leave
• Low cost medical, dental, and pharmacy plans
• Health care and dependent daycare flexible spending accounts
• Excellent retirement plans with employer match
• Disability and employer paid life insurance
• Wellbeing program with reduced insurance premiums
• Tuition reimbursement opportunities covering 75%-100% of eligible tuition
• Employee Assistance Program
For more information regarding benefits please click here.

All required qualifications must be documented on application materials

Required Qualifications:
• BA/BS with at least 4 years of research experience or an advanced degree plus 2 years of experience or a combination of related education and work experience to equal 8 years
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as a part of a team, and with changing prioritie
• Demonstrated ability to lead projects, set and maintain deadlines and prioritize assignments.
• Excellent written, verbal and interpersonal skills
• Strong MS Office and Adobe experience, and familiarity with Google Suite. Ability to adapt and learn a variety of databases, systems, and software platforms
• Ability to work flexible work hours, including some early mornings, evenings, and weekends as well as be on call as needed for studies
• Ability to complete and maintain requirements for NERS approval with Fairview Research Administration

Preferred Qualifications:
• BA/BS in health, public health, or biomedical disciplines, or experience in clinical research or a clinical setting
• Familiarity with University of Minnesota, and MHealth hospitals and clinics
• Experience working on a multi-disciplinary team.
• Experience with research database software including REDCap, Oncore, Epic, and Microsoft Access