Cerebrovascular Laboratory Clinical Trials Research Assistant

The Cerebrovascular Research Lab in the University of Iowa Department of Neurology is seeking a post-baccalaureate Clinical Trials Research Assistant to manage research study participation including subject recruitment scheduling retention and enrollment. This individual will also administer study protocols and oversee data processing and cleaning.

Responsibilities include:

• Participate in the design development and testing of clinical research trials data systems.
• Prepare information upon request for reporting to funding source(s).
• Assist in the preparation of material for reports and/ or grant submissions to be written by faculty and staff regarding research projects.
• Respond to inquiries about assigned projects and present at informational sessions and panel discussions as requested.
• Recruit potential study participants via applicable clinics and impatient hospitalizations.
• Screen potential study participants based upon project criteria.
• Track and follow up with prospective study participants within project guidelines.
• Manage the scheduling of testing and appointments including arrangement of travel on-site room and equipment reservations
• coordination of the test day agenda and confirmation of arrangements with scheduled study participants and applicable multi-departmental study team members.
• Educate study participants on scope of study potential risks and benefits possible alternatives and study requirements for participants.
• Obtain informed consent and other required regulatory documents and monitor participant experience for reportable events.
• Maintain contact information of project participants in a secure database and proactively manage scheduling of follow up study visits to comply with project longitudinal goals.
• Score and record data collected; perform and oversee data entry and data audits.
• Maintain computerized databases primarily REDCap.
• Revise and implement change in data collection and databases as indicated.
• Validate data review query reports and make recommendations for resolutions.
• Initiate meetings with the biostatistical team to ensure data properly reflects study aims and goals. Perform chart review for data collection within protocol guidelines.
• Manage and monitor compliance of regulatory guidelines and proper maintenance of documents; prepare regulatory submissions.
• Communicate with IRB and FDA staff and investigators resolve all monitoring visit issues and recommend corrective action for reportable events.
  

Principal Investigator:
Edgar A. Samaniego MD MS
Associate Professor of Neurology Neurosurgery and Radiology
The University of Iowa Hospitals and Clinics

Pay Grade: 3A - of Time: 100%

Please note: This is a specified term position that will last 12 months. An extension may be reviewed after the initial 12 months but is not guaranteed.