Clinical Trials Research Associate/Assistant - Radiology

The University of Iowa Health Care Department of Radiology is hiring a Clinical Trials Research Associate/Assistant to support the planning, coordination, and execution of clinical research studies and trials. The role coordinates participant recruitment and study activities, maintains research data and regulatory documentation, and helps ensure compliance with study protocols and institutional requirements.

Responsibilities

• 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
• 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
• 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
• 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
• 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

Preferred

• 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
• ACRP or SoCRA Certification
• Ability to work independently and manage multiple priorities or studies at one time
• Clinical Trial Experience
• Epic
• REDCap
• ClinicalTrials.gov
• IRB Submission Systems
• Blood Draws
• IV Placement
• Specimen Processing
• Specimen Storage
• Laboratory Maintenance
• Inventory Management
• Supply Ordering
• IRB Procedures
• ACRP Certification
• SoCRA Certification
• Independent Work
• Prioritization
• Multitasking

Benefits

• Paid vacation
• Sick leave
• Health insurance options
• Dental insurance options
• Life insurance options
• Disability insurance options
• Generous employer contributions into retirement plans

Company

• University research support, compliance, and core facilities services
• Iowa City, Iowa, US
• https://research.uiowa.edu/
• 1001-5000 employees

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
• 2-4 years experience with and participation on clinical trials
• Experience with research protocol management
• Knowledge of IRB regulatory guidelines and procedures
• Experience with medical research data 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
• ACRP or SoCRA Certification
• Ability to work independently and manage multiple priorities or studies at one time

Required skills

• ACRP Certification, Adobe Acrobat, Blood Draws, Clinical Research Data Management, Clinical Research in Hospital or Clinical Settings, Clinical Trials, ClinicalTrials.gov, Epic, IRB Regulatory Guidelines and Procedures, IV Placement, Microsoft Office Excel, Microsoft Office Outlook, Microsoft Office PowerPoint, Microsoft Office Word, REDCap, Research Protocol Management, SoCRA Certification, Specimen Processing

Preferred skills

• ACRP or SoCRA Certification, Experience and participation with clinical trials

Experience

• 1+ years