Duties/responsibilities:

Provide clinical research assistance to faculty in the Department of Radiation Oncology performing clinical research. Serving as a lead/research project manager: Implement, manage, coordinate, and document research protocols and study activities; ensure that all components of a project are completed in an ethical, scientific, rigorous, and timely manner.

Protocol/Study Management (45%)
• Duties are determined by protocol-specific requirements and may include any research activity from protocol development through study closeout. The incumbent may assume responsibility for continuity of research subject care and follow the subject from beginning to completion of the study
• Facilitate the successful implementation of the IRB approved protocol; read and interpret clinical protocols, assess study related needs, and provide input to facilitate implementation.
• Demonstrate effective and efficient communication with study sponsors, monitors, department and University staff
• Complete and maintain essential, source, and regulatory documents.
• Organize data collected into databases, spreadsheets and reporting mechanisms, and ensure accuracy of data entry
• Handle basic financial, personnel and administrative transactions (ex: study participant payments and supply purchasing)

Manage subject participation in research protocol (40%)
• Recruit potential subjects across the M Health Fairview clinical enterprise
• Participate in protecting the rights of research subjects via execution of informed consent and compliance with HIPPA requirements
• Determine subject eligibility, and maintain compliance with protocol eligibility requirements
• Perform study specific procedures for the collection of research data
• Collect and ship specimens for research, laboratory, or clinical testing as required
• Maintain study databases to track the status of participants
• Follow up study participants via data collection from medical records, in person interviews, and by telephone
• Review data collection forms for completeness and accuracy, and abstract data from medical records using standard forms

Education and Administration (10%)
• Educate University faculty and staff of our regulatory and research obligations in relation to our clinical research activities
• Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care; including attendance at weekly tumor boards.
• Facilitate new project development
• Support quality improvement initiatives
• Attend research and professional development trainings as appropriate

Pre-Award and Budgeting (5%)
• Support investigators in the submission of research proposals, including cost build up for budget development
• Serve as departmental interface with Clinical Trials office for supporting budget development and negotiations with research sponsors
• Track and monitor clinical trial accrual data at a department level 

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.

Qualifications
Required:
• Bachelor’s degree with at least 5 years of related clinical trials research experience or an advanced degree with 3 years of experience, or a combination of related education and work experience to equal 9 years.
• Demonstrated proficiency with basic office software such as Microsoft Office, and databases (especially Microsoft Excel).
• Ability to work independently, problem solve, and priorities the simultaneous management of multiple projects
• Strong organizational, communication and time management skills. Must be able to represent studies and the University in a positive and professional way.
• Ability to collaborate and communicate with the entire spectrum of study participants and stakeholders including principal investigators, researchers, managers, clinic personnel, and study sponsors.
• Must be able to document all phases of the research process utilizing exceptional organizational skills to ensure smooth study implementation and progression.
• Previous experience providing oversight for grant proposals and budgets.

Preferred:
• Certification as a Clinical Research Coordinator (CCRC, CCRP, or similar certification)
• Familiarity with medical terminology and electronic medical records
• Previous experience building clinical trials budgets, including budget negotiations with sponsoring agencies
• Familiarity with University of Minnesota and University of Minnesota Medical Center Fairview Hospitals and Clinics
• Prior experience in database management, statistics, and writing of scientific reports is highly desirable
• Experience with research database software including REDcap, OnCore, and Microsoft Access
• A keen interest in clinical outcomes research and patient care is important, with a demonstrated education record including courses in epidemiology or health sciences research and statistical methods
• Critical thinker and detail oriented