Clinical Research Assistant - Pediatric Hematology/Hemostasis

UIOWA•Iowa City, IA

23h

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, detail-oriented Research Assistant to support clinical research studies focused on bleeding and clotting disorders. The position coordinates research protocols from regulatory and administrative activities through participant recruitment and enrollment, study visits, data collection and entry, and data quality assurance. The successful candidate serves as the primary coordinator for studies and works with investigators, research staff, patients, and families to support protocol compliance and study completion. The role also involves coordinating data management and quality activities, maintaining regulatory records, supporting study procedures and specimen handling, and serving as a liaison among participants, healthcare providers, research teams, sponsors, regulatory agencies, and other stakeholders. Functional supervision, training, and mentorship of new staff may be assigned. The Stead Family Department of Pediatrics provides clinical care, conducts research, and educates pediatric healthcare providers. It comprises the medical and research staff of UI Stead Family Children’s Hospital, a comprehensive children’s hospital and pediatric care and research institution. This is a Specified Term role. Applicants must upload a resume and cover letter and mark each as a “Relevant File.” The position is not eligible for University sponsorship for employment authorization. Successful candidates must disclose conviction history and undergo a criminal background check and credential/education verification.

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.
Proficiency in computer software applications, including spreadsheet and database experience.
Experience coordinating multiple projects and functions independently.
Knowledge of regulations that apply to human research.

Nice To Haves

Interest in pursuing clinical trials research in 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 participants, study drugs, biological specimens, study procedures, and research data.
Read, interpret, and discuss research protocols with potential participants and other stakeholders.
Educate patients and families about study objectives, procedures, risks, benefits, alternatives, and participant responsibilities.
Screen, recruit, enroll, and obtain informed consent from participants.
Schedule participant visits, procedures, and follow-up activities according to 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 accurately and in a timely manner.
Assess data quality, determine data validity and completeness, and identify and resolve discrepancies.
Generate and resolve data queries, manage data validation activities, and prepare required data reports.
Coordinate data collection and processing across multiple sites, centers, and studies.
Conduct quality assurance activities, including data 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 protocol-related forms and documentation.
Ensure compliance with regulatory requirements, study protocols, institutional policies, and documentation standards.
Assist with resolution of monitoring visit findings, report adverse 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.
Provide functional supervision, training, and mentorship to new staff as assigned.