The Clinical Research Assistant will work with the clinical research faculty on a variety of research studies to include; business and industry studies and investigator-initiated studies. This position reports to the Dermatology Clinical Research Manager. The research assistant is a key team member for the clinical research studies across the adult and pediatric populations. Projects will range from Phase 2 drug studies to low risk research registries. Troubleshooting and independent problem solving skills will be important in this role. In addition, the position collaborates with other areas of the University to include Clinical Transitional Science Institute (CTSI) clinical research services, and the staff in the Dermatology clinics and research clinic in assuring that studies meet regulatory requirements and are completed according to protocol.
Major Duties/Job Description: Research Assistant / Coordination Duties Include: (70%)
Facilitate the successful implementation of the IRB approved protocols; read protocols and interpret clinical protocols, assess study related needs, and provide input to facilitate implementation under the supervision of the department’s research manager.
Develop a system to track and schedule subject visits to ensure study protocol timelines are met.
Manage study data collection and entry, as directed, through patient interactions, electronic medical records, etc.
Responsible for effective specimen management, including preparing kits, preparing shipments, and tracking inventory.
Responsible for accuracy of all study and subject data entry into the OnCore clinical trials management system to ensure billing compliance for required sponsor platforms.
Evaluate study progress regularly, and provide input to integrate improvements.
Work collaboratively with, advise, and support the Sr. Clinical Research Coordinator (CRC, Research Professional 3) and Investigators with regards to the timely review and reporting of adverse reactions and severe adverse events.
Demonstrate effective and efficient communication among Principal Investigators, University departments, outside sponsors, clinical partners, and collaborators.
Oversee and process payments for study supplies and equipment, and study participant reimbursement.
Regulatory Documentation (15%)
Prepare for and participate in site initiation visits, monitoring visits, and program audits.
Create and maintain source documents, regulatory subject binders, standardized processes, and required documentation. Evaluate all documentation for completeness and accuracy to ensure compliance and to be audit-ready at any given time.
Complete and manage regulatory tasks as assigned.
Administration Activities (10%)
Advise and support the clinical research team regarding new project development and start-up activities.
Facilitate and coordinate patient scheduling and appointment reminders.
Work collaboratively with Clinical Research Coordinator and Investigators to develop and implement a study recruitment plan that is protocol compliant.
Participate in quality improvement initiatives.
Contribute to weekly clinical research meetings.
Additional tasks as assigned.
Attend CTSI CRP Professional Development Seminars and other educational opportunities as appropriate.
Engage with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care.
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
All required qualifications must be documented on application materials.
Bachelors’ degree and 2 years of clinical or research experience or a combination of related education and work experience to equal 6 years.
Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good Clinical Practice guidelines.
Computer proficiency and ability to navigate multiple software applications.
Detail-oriented with exceptional organizational, planning and problem-solving skills.
Ability to work in a complex environment.
Ability to work independently, as a part of a team and with changing priorities.
Possess excellent communication (written and verbal) and interpersonal skills.
Ability to work flexible work hours, potentially rare evenings and weekends.
Ability to multi-task and manage projects simultaneously.
Experience reading and interpreting scientific literature.
Previous experience with Dermatology.
Experience in both adult and pediatric studies.
Relevant and direct experience with regulatory requirements including study monitoring, Institutional Review Board submissions, Investigation New Drug (IND) and/or Investigational Device (IDE) submissions.
Experience with Epic or other electronic medical record systems.
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.