Clinical Trials Research Assistant/Data Manager- Radiology

Position Overview

The University of Iowa Health Care Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager to support the coordination and management of clinical research studies and trials.

Responsibilities

• Research/Clinical Activities:
  • Screens, recruits, consents, enrolls, assesses and monitors subjects for both general research and clinical trial projects.
  • Assists with subject recruitment by mining databases and EPIC.
  • Aids in clinical and data coordination for research activities and sets up supplies for study visits.
  • Participates in clinical research visits, which includes Epic documentation, checking vitals, providing research questionnaires, patient education, and coordinating future research visits.
  • Serves as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs.
  • Schedules and coordinates study visits, procedures, imaging, laboratory testing, and follow-up appointments.
  • Prepares and manages investigational decisions, procedural kits, and study supplies.
  • Covers post-procedure monitoring, discharge instructions, and follow-up care.
  • Collects and documents clinical assessments, labs, imaging, radiation exposure, and contrast use.
  • Reports adverse events, serious adverse events, and unanticipated problems.
• Data Collection and Monitoring:
  • Aids in managing data, including the storage, reporting, and auditing to assess quality assurance.
  • Performs all data processing tasks; enters data, verifies data, generates queries, etc.
  • Coordinates the processing of data from various sites/centers/studies.
  • Ensures accurate documentation of procedural, device, and imaging data.
  • Responds to data queries and maintains data quality.
  • Prepares for and participates in monitoring visits and audits.
  • Maintains drug/device accountability and reconciliation logs.
• Regulatory Guidelines and Documents:
  • Aids in the submission of IRB protocols, works with department Regulatory Specialist to ensure timely updating of information for submissions.
  • Ensures compliance with GCP, FDA regulations, and institutional policies.
  • Maintains training and delegation documentation.
  • Supports regulatory audits and inspections.
  • Supports protocol development and management.
• Human Resources/Leadership:
  • May provide training to other research staff as required by the study protocol.

Qualifications

• A Bachelor's degree in STEM (Science, Technology, Engineering, or Math) or related educational field, or an equivalent combination of education and experience.
• 6 months of clinical research experience.
• Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information.
• Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat.
• Excellent written, verbal communication, interpersonal and organizational skills.
• Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study.

Desirable Qualifications

• Experience with research protocol management.
• Experience with protocol and medical research data management.
• Experience and participation with clinical trials.
• Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems.
• Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders.
• Knowledge of IRB regulatory guidelines and procedures.