Clinical Research Assistant - Pediatric Hematology/Hemostasis

UIOWA • Iowa City, IA

2d • Onsite

About The Position

The Hematology/Hemostasis Research Team in the UI Stead Family Department of Pediatrics and Division of Hematology/Oncology is seeking a motivated and detail-oriented Research Assistant to support a variety of clinical research studies focused on bleeding and clotting disorders. This position involves coordinating all aspects of clinical research protocols, including regulatory and administrative requirements, participant recruitment and enrollment, study visit coordination, data collection and entry, and data quality assurance. The successful candidate will serve as the primary coordinator for research studies while collaborating closely with investigators, research staff, patients, and families to ensure protocol compliance and successful study completion. Strong organizational skills, attention to detail, reliability, and excellent interpersonal and communication abilities are essential for managing multiple responsibilities and maintaining high standards of research integrity and participant engagement. This position is a Specified Term role.

Requirements

• Bachelor’s degree in a health science related field
• Proven ability to utilize medical terminology
• Excellent organizational and time-management skills, and attention to detail
• Excellent written and verbal communication skills
• Proficient in computer software applications including spreadsheet and database experience
• Experience in coordinating multiple projects and multiple functions independently
• Knowledge of regulations that apply to human research

Nice To Haves

• Interest in pursuing clinical trials research in the area of Hematology/Oncology
• Prior experience with Institutional Review Board application materials and processing
• Experience in study design, database design, and/or data analysis

Responsibilities

• Consult with researchers to develop data management plans and coordinate clinical and data management activities for research studies.
• Design, implement, and field test data collection forms and systems for tracking study participants, study drugs, biological specimens, study procedures, and research data.
• Read, interpret, and discuss complex research protocols with potential study participants and other stakeholders.
• Educate patients and families regarding study objectives, procedures, risks, benefits, alternatives, and participant responsibilities.
• Screen, recruit, enroll, and obtain informed consent from participants for clinical trials and research studies.
• Schedule participant visits, study procedures, and follow-up activities in accordance with protocol requirements.
• Meet with participants during study visits and provide ongoing study support and coordination.
• Perform or assist with patient assessments, review medical histories, and support protocol-required study procedures.
• Obtain, process, track, and manage clinical trial specimens and other study materials.
• Collect, enter, verify, maintain, and process clinical research data in a timely and accurate manner.
• Assess data quality, determine validity and completeness of data, and identify and resolve data discrepancies.
• Generate and resolve data queries, manage data validation activities, and prepare required data reports.
• Coordinate data collection and processing activities across multiple sites, centers, and studies.
• Conduct quality assurance activities, including data audits and on-site audits, and develop audit procedures as needed.
• Summarize audit findings, prepare reports, and implement follow-up actions to support data quality and protocol compliance.
• Collect, maintain, and prepare regulatory documents, study records, and required protocol-related forms and documentation.
• Ensure compliance with regulatory requirements, study protocols, institutional policies, and documentation standards.
• Assist with the resolution of monitoring visit findings, report adverse events and other reportable events, and support regulatory communications.
• Serve as a liaison among study participants, healthcare providers, research teams, sponsors, regulatory agencies, and other stakeholders.
• Assist with study budget development and monitoring and provide functional supervision, training, and mentorship to new staff as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level