Clinical Trials Research Assistant/Data Manager- Radiology

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager! The Clinical Trials Research Assistant/Data Manager is responsible for performing clinical/health care research activities in support of clinical trials in the Department of Radiology. Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Screen recruit, enroll and obtain informed consent of clinical research activities. Participate in the design, development, and testing of clinical research trial data systems. Mange and organized regulatory documentation.

Position Responsibilities:

Key Areas of Responsibility

• Research/Clinical Activities; Subject Recruitment and Enrollment

  • Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects.

  • Assist with subject recruitment by mining databases and EPIC.

  • Assist with clinical and data coordination for research activities and set up supplies for study visits.

  • Participates in clinical research visits, which includes Epic documentation, checking vitals, provision of research questionnaires, patient education, and coordination of future research visits

  • Coordinate day-today clinical trial operations within the procedural environment

  • Serve as primary liaison among participants, investigators, clinical staff, sponsors, CROs, and imaging core labs

  • Schedule and coordinate study visits, procedures, imaging, laboratory testing, and follow-up appointments

  • Prepare and manage investigational decides, procedural kits, and study supplies

  • Coordinate post-procedure monitoring, discharge instructions, and follow-up care

  • Collect and document clinical assessments, labs, imaging, radiation exposure, and contrast use

  • Track and report adverse events, serious adverse events, and unanticipated problems

  • Provide patient education related to procedures, medications, and follow-up requirements

• Data Collection and Monitoring

  • Assist in managing data, including the storage, reporting and auditing to assess quality assurance

  • Perform all data processing tasks; enter data, verify data, generate queries, etc. 

  • Coordinate the processing of data from various sites/centers/studies

  • Ensure accurate documentation of procedural, device, and imaging data

  • Respond to data queries and maintain data quality

  • Prepare for and participate in monitoring visits and audits

  • Maintain drug/device accountability and reconciliation logs

• Regulatory Guidelines and Documents

  • Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions

  • Ensure compliance with GCP, FDA regulations, and institutional policies

  • Maintain training and delegation documentation

  • Support regulatory audits and inspections

• Protocol Development/Management and Study Responsibilities

  • Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures

  • Design and coordinate field tests for data collecting forms and assist in the design of these procedures

  • Manages and maintain protocols

  • Research, change, and submit protocol amendments for IRB approval

  • Prepares IRB documents for protocol approval, modifications and yearly renewals

  • Monitors protocol status as it is process through the IRB

  • Assist in conducting training of new protocols and changes to existing protocols

  • Assist with feasibility assessments and study start-up activities

  • Review protocols for operational feasibility and workflow integration

  • Coordinate site initiation, investigator meetings, and sponsor communications

  • Support in tracking study milestones, enrollment targets, and budgets

  • Support study close-out activities and document archiving

• Human Resources/Leadership

  • May provide training to other research staff as required by the study protocol

     

     

     

    The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job.

     

     

     

    University of Iowa Health Care—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives.^® 

Percent of Time: 100%

Schedule: Mon - Fri 8:00 am – 4:30 pm

Location: Iowa City, IA

Pay Grade: 3A https://hr.uiowa.edu/pay/guide-pay-plans