Clinical Trials Research Associate - Radiology

University of Iowa•Iowa City, IA

4d•Onsite

About The Position

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.

Requirements

A Bachelor's degree in STEM (Science, Technology, Engineering, or Math) or related educational field, or an equivalent combination of education and experience
Considerable (2-4 years) experience with and participation on clinical trials
Experience with research protocol management
Experience with protocol and medical research data management
Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information
Knowledge of IRB regulatory guidelines and procedures
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

Nice To Haves

Experience with medical research data management
Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems
ACRP or SoCRA Certification
Ability to work independently and manage multiple priorities or studies at one time.

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
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
Supports leadership with staffing, coverage planning, and resource needs