Clinical Trials Research Assistant/Data Manager- Radiology

The University of Iowa Health Care Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager to support the coordination and management of clinical research studies and trials. This position assists with the design, development, implementation, administration, and maintenance of clinical trial protocols while ensuring accurate data collection and regulatory compliance. Responsibilities include screening, recruiting, enrolling, and obtaining informed consent from research participants, coordinating study activities, managing clinical research data and trial databases, and maintaining organized regulatory documentation. The Clinical Trials Research Assistant/Data Manager plays a critical role in supporting high-quality clinical research that advances patient care and medical innovation.

Position Responsibilities

Research/Clinical Activities; Subject Recruitment and Enrollment

• Screens, recruits, consents, enrolls, assesses and monitors subjects for both general research and clinical trial projects
• Assists with subject recruitment by mining databases and EPIC
• Assists with clinical and data coordination for research activities and set up supplies for study visits.
• Participates in clinical research visits, which includes Epic documentation, checking vitals, provision of research questionnaires, patient education, and coordination of future research visits
• Coordinates day-today clinical trial operations within 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 manage investigational decides, procedural kits, and study supplies
• 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

• Assists in managing data, including the storage, reporting and auditing to assess quality assurance
• Performs all data processing tasks; enter data, verify data, generate queries, etc.
• Coordinates the processing of data from various sites/centers/studies
• 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

• Assists with the submission of IRB protocols, works with department Regulatory Specialist to ensure timely updating of information for submissions
• 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

• Consults with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures
• Designs and coordinates field tests for data collecting forms and assist in the design of these procedures
• 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
• Assists with training of new protocols and changes to existing protocols
• Assists with feasibility assessments and study start-up activities
• Reviews protocols for operational feasibility and workflow integration
• Coordinates site initiation, investigator meetings, and sponsor communications
• Supports in tracking study milestones, enrollment targets, and budgets
• Supports study close-out activities and document archiving

Human Resources/Leadership

• May provide training to other research staff as required by the study protocol

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: 3A 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.
• For more information about Why Iowa? Click here

Education Requirements

• A Bachelor's degree in STEM (Science, Technology, Engineering, or Math) or related educational field, or an equivalent combination of education and experience

Experience Requirements

• 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
• 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

Desirable Qualifications

• 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

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. For questions, please reach out to Lori Steffens at lori-steffens@uiowa.edu.

• Job openings are posted for a minimum of 14 calendar days or until position is filled

• Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check

Additional Information

• Classification Title: Clin Trials Rsrch Asst/Data Mg
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

• Pay Level: 3A

Contact Information

• Organization: Healthcare
• Contact Name: Lori Steffens
• Contact Email: lori-steffens@uiowa.edu