Clinical Trials Research Associate - Radiology

The University of Iowa Health Care Department of Radiology is seeking a Clinical Trials Research Associate to support the planning, coordination, and execution of clinical research studies and trials. This position is responsible for assisting with the design, development, implementation, administration, and maintenance of clinical trial protocols while ensuring compliance with regulatory and institutional requirements. The Clinical Trials Research Associate will screen, recruit, enroll, and obtain informed consent from research participants, coordinate study activities, manage and maintain regulatory documentation, and assist in the development and testing of clinical research data systems. This role plays a vital part in advancing innovative research that supports improvements in patient care and medical discovery.

Position Responsibilities

Research/Clinical Activities; Subject Recruitment and Enrollment

• Educates study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants
• Screens, recruits, consents, enrolls, assesses and monitors subjects for both general research and clinical trial projects.
• Oversees the recruitment of subjects and scheduling off trial-related procedures
• Educates study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants
• Relays information to the principal investigator and verify study participant eligibility
• Identifies potential participants through clinics, imaging reports, and procedure schedules
• Conducts eligibility screening and maintain screening and enrollment logs
• Coordinates and documents informed and retention strategies
• Maintains confidentiality and comply with HIPAA requirements
• Participates in clinical research visits, which includes Epic documentation, checking vitals, precision of research questionnaires, patient education, and coordination of future research visits
• Coordinates day-to-day clinical trial operations withing the procedural environment
• 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 devices, procedural kits, and study supplies
• Supports informed consent process per protocol and institutional policy
• Coordinates post-procedure monitoring, discharge instructions, and follow-up care
• Collects and documents clinical assessments, labs, imaging, radiation exposure, and contrast use
• Tracks and reports adverse events, serious adverse events, and unanticipated problems
• Provides patient education related to procedures, medications, and follow-up requirements

Data Collection and Monitoring

• Participates in the design, development and testing of clinical research trials data systems
• Validates data, query resolution, and make recommendations for resolution
• Revises and implements change in data collection
• Coordinates the processing of data from various sites/centers/studies
• Collects, enters, and verifies source data and electronic case report forms
• Ensures accurate documentation of procedural device, and imaging data
• Responds to data queries and maintain data quality
• Prepares for and participates in monitoring visits and audits
• Maintains drug/device accountability and reconciliation logs

Regulatory Guidelines and Documents

• Manages and organizes regulatory documentation from site and regulatory authorities; Prepares regulatory submissions
• Performs on-site audits of research and clinical data
• Monitors compliance with regulatory guidelines and proper maintenance of documents
• May recommend corrective action for reportable events
• May communicate with IRB staff and investigators
• Maintains complete and up-to-date regulatory binders and investigator site files
• Prepares and submits IRB applications, amendments, continuing reviews, and safety reports
• Ensures compliance with GCP, FDA regulations, and institutional policies
• Maintains training and delegation documentation
• Supports regulatory audits and inspections

Protocol Development/Management and Study Responsibilities

• Assists in the design, development, execution administration, and maintenance of protocols and clinical studies
• Assists in study design and protocol development and provide input into descriptions of complex research procedures
• Oversees CRF development
• Reviews query reports
• Resolves all monitoring visit issues
• Performs and monitors randomizations
• Develops complex study materials
• Serves as a liaison to local health care practitioners, agencies, and sponsors
• Manages and maintains protocols
• Researches, changes, and submits 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
• Conducts training of new protocols and changes to existing protocols
• Completes feasibility assessments and study start-up activities
• Reviews protocols for operational feasibility and workflow integration
• Coordinates site initiation, investigator meetings, and sponsor communications
• Tracks study milestones, enrollment targets, and budgets
• Conducts study close-out activities and document archiving

Human Resources/Leadership

• May provide functional and/or administrative supervision; Mentor new staff under direction
• Coordinates multidisciplinary teams and clinical workflows
• Prepares for and participates in monitoring visits and audits
• Supports leadership with staffing, coverage planning, and resource needs

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: 4A https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights:

• Regular salaried position located in Iowa City, Iowa.
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
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