Clinical Trials Research Associate - Radiology

University of Iowa • Iowa City, IA

5d • Onsite

About The Position

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Associate! The Clinical Trials Research Associate 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.

Requirements

• Bachelor’s Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required.
• Considerable (2-4 years) experience with and participation on clinical trials is required.
• Excellent written, verbal communication, interpersonal and organizational skills are required.
• 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.
• 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
• Previous research protocol management experience is required
• Knowledge of regulatory guidelines and procedures is required.
• Experience with protocol and medical research data management is required.

Nice To Haves

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

Responsibilities

• Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects.
• Oversee the recruitment of subjects and scheduling off trial-related procedures
• Educate study participants on the scope of the study, potential risks and benefits, possible alternatives, and requirements for participants
• Relay information to the principal investigator and verify study participant eligibility
• Identify potential participants through clinics, imaging reports, and procedure schedules
• Conduct eligibility screening and maintain screening and enrollment logs
• Coordinate and document informed and retention strategies
• Maintain 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
• Coordinate day-to-day clinical trial operations withing 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 devices, procedural kits, and study supplies
• Support informed consent process per protocol and institutional policy
• 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
• Participate in the design, development and testing of clinical research trials data systems
• Validate data, query resolution, and make recommendations for resolution
• Revise and implement change in data collection
• Coordinate the processing of data from various sites/centers/studies
• Collect, enter, and verify source data and electronic case report forms
• 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
• Manage and organize regulatory documentation from site and regulatory authorities.
• Prepare regulatory submissions
• Perform on-site audits of research and clinical data
• Monitor compliance with regulatory guidelines and proper maintenance of documents
• May recommend corrective action for reportable events
• May communicate with IRB staff and investigators
• Maintain complete and up-to-date regulatory binders and investigator site files
• Prepare and submit IRB applications, amendments, continuing reviews, and safety reports
• Ensure compliance with GCP, FDA regulations, and institutional policies
• Maintain training and delegation documentation
• Support regulatory audits and inspections
• Assist in the design, development, execution administration, and maintenance of protocols and clinical studies
• Assist in study design and protocol development and provide input into descriptions of complex research procedures
• Oversee CRF development
• Review query reports
• Resolve all monitoring visit issues
• Perform and monitor randomizations
• Develop complex study materials
• Serve as a liaison to local health care practitioners, agencies, and sponsors
• 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
• Responsible for conducting training of new protocols and changes to existing protocols
• Responsible for feasibility assessments and study start-up activities
• Review protocols for operational feasibility and workflow integration
• Coordinate site initiation, investigator meetings, and sponsor communications
• Track study milestones, enrollment targets, and budgets
• Responsible for study close-out activities and document archiving
• May provide functional and/or administrative supervision. Mentor new staff under direction
• Coordinate multidisciplinary teams and clinical workflows
• Support leadership with staffing, coverage planning, and resource needs

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees