Clin Trials Rsrch Asst/Data Mg - ICTS Coordinator Core

About the role

The Institute for Clinical and Translational Science (ICTS) is seeking a Clinical Trial Research Assistant/Data Manager to join the ICTS Coordinator Core as an integral member of our research team. This position provides essential research support by performing activities critical to advancing the ICTS research mission, strengthening research infrastructure, and fostering innovation through collaborative research support.

Responsibilities

• Research/Clinical Activities:
  • Perform clinical/health care research activities in various departments
  • Screen, recruit, enroll and obtain informed consent for clinical research activities
  • Relay information to principal investigator and verify patient eligibility
  • Administer study treatments and report adverse reactions
  • Schedule and oversee trial-related procedures
  • Prepare study recruitment materials
• Protocol Development/Management and Study Responsibilities:
  • Aid in the design, development, execution, administration and maintenance of protocols and clinical studies
  • Provide input into descriptions of complex research procedures
  • Assist patients with problems related to protocol
  • Oversee CRF development and database development and maintenance
  • Resolve query reports and monitor compliance of regulatory guidelines
  • Develop complex study materials
  • Act as liaison to local health care practitioners, agencies, and sponsors
• Data Collection and Monitoring:
  • Design, develop and test clinical research trial data systems
  • Liaise between health care clinical information systems and research data systems
  • Validate data and make recommendations for resolution
• Regulatory Guidelines and Documents:
  • Manage and organize regulatory documentation
  • Prepare regulatory submissions
  • Perform on-site audits of research and clinical data
• Financial Responsibility:
  • Participate in preparation of grant applications for extramural funding
  • Track and reconcile grant/trial budget free balances
  • Identify opportunities to ensure grant funding is used as intended and awarded

Qualifications

• A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience
• Excellent written and verbal communication skills
• Ability to work nights and weekends
• Proficiency in Microsoft Word, Outlook and Excel
• Basic clinical research experience
• Working knowledge of Good Clinical Practice (GCP)
• Previous experience writing manuscripts for publication
• Experience with REDCap, Epic, I-CART, and ACCESS
• Previous experience in data collection and entry
• Experience in processing research regulatory documents
• A current license to practice nursing in Iowa by the time of hire
• The ability to work independently
• Excellent time management skills and ability to perform detail-oriented work

Benefits

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

Pay

Pay Grade: 3A

Contact Information

Organization: Healthcare
Contact Name: Amy Stewart
Contact Email: amy-stewart@uiowa.edu