Clinical Trials Research Associate - Radiology
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.
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.
- 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
- Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects.
- Data Collection and Monitoring
- 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
- Participate in the design, development and testing of clinical research trials data systems
- Regulatory Guidelines and Documents
- 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
- 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
- Manage and organize regulatory documentation from site and regulatory authorities. Prepare regulatory submissions
- Protocol Development/Management and Study Responsibilities
- 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
- Assist in the design, development, execution administration, and maintenance of protocols and clinical studies
- Human Resources/Leadership
- 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
- May provide functional and/or administrative supervision. Mentor new staff under direction
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
Required Qualifications:
- 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.
Desirable Qualifications:
- 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.
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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Application Process:
To be considered, applicants must upload a resume and a cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position.
Job openings are posted for a minimum of 14 calendar days. Applications will be accepted until position is filled.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check. For additional questions, please contact Lori Steffens at lori-steffens@uiowa.edu.
Equal opportunity employer
The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
