Provides professional services for studies funded through SeroNet, a NIH funded study evaluating antibody response to COVID-19 infection and other studies in the Department of Laboratory Medicine and Pathology. Projects will include coordination, collaboration, and communication with investigators, patients, research participants, sponsors, clinical care or research teams, as well as other applicable institutional authorities. The study coordinator will be responsible for a variety of activities in the research cycle, including study feasibility, onboarding, recruitment, screening, pre/peri/post study visits, medical record review, data entry, subject retention, regulatory and budgetary compliance, and study close-out. The applicant will primarily work independently with day to day activities; and report to Dr. Thyagarajan.
TYPICAL TASKS (These examples do not include all possible tasks in this work and do not limit the assignment of related tasks in any position of this class.)
Participant related activities and data management (60%) - Identify and follow study participants, accurately completing visit procedures and data collection according to the protocol while maintaining the health and safety of research subjects.
Understand and interpret clinical protocols, assess study needs, develop plans for successful implementation, conduct and document visits, evaluate progress regularly, and provide input to integrate improvements.
Develop methods to identify potential participants such as via database searches and collaboration with internal and external partners.
Obtain research consent/HIPAA and screen patients for eligibility based on medically complex inclusion and exclusion criteria, seeking investigator input as appropriate. Educate the patient as well as the legally authorized representative or family when applicable throughout the research participation process.
Develop and maintain accurate source documentation.
Document research findings and data according to protocol requirements and timeline.
Interpret study/medical results to families and /or health care staff and report significant findings to appropriate study staff.
Assess, troubleshoot, and report adverse events or problems with data collection or other research processes.
Administrative (20%) - Provide study-specific leadership and day-to-day supervision to meet key benchmarks in the areas of study setup, participant recruitment and retention rates, development and implementation of data management systems, and reporting responsibilities.
Initiate and participate in project update meetings
Provide assistance in defining and working through study logistics and feasibility
Serve as subject matter expert in clinical-related and health care topics
Collaborate with other disciplines involved in the research process. Demonstrate effective and efficient communication with study sponsors, monitors, study/department staff, and health team members
Provide ongoing quality control audits and implement improvements as needed
Maintain departmental research database; obtain and publish updates of study progress
Coordinate site visits, audits
Order Research supplies
Regulatory (20%) - Ensure adherence to research protocols, Good Clinical Practices (GCP), IRB, FDA and other applicable federal, state or local regulations. Assist in the timely preparation and maintenance of compliance and regulatory documents from the initial submission through study closure.
Oversee regulatory conditions of studies
Assist with development of clinical research protocol documentation
Report findings and adverse events as applicable
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
· Student loan forgiveness opportunity
· Opportunities for growth and promotion
· Employee Assistance Program
For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2021_tcd-cslr-75100-ben-0105-7_final.pdf
All required qualifications must be documented on application materials
Bachelor’s degree in a health related field with at least 2 year of work experience in research; or a combination of related education and work experience in research totaling 6 years
Demonstrated ability to operate independently under general supervision of the Principal Investigators while maintaining the integrity of research projects.
Candidate should be able to proactively identify and solve problems to keep research projects in compliance with requirements.
Candidate will operate in a professional leadership capacity on the team and should demonstrate skills in prioritization, organization, delegation, flexibility, and multi-tasking.
Expertise with navigating electronic health records and interpreting medical terminology.
Experience collaborating with clinical and research faculty in an academic setting
Experience with research database software including REDCap, Oncore and Epic
Ability to work independently, make decisions, problem solve and prioritize thesimultaneous management multiple clinical studies.
Experience with IRBs
Familiarity with the University of Minnesota Medical Center-Fairview hospital andclinics.
Internal Number: 341187
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.