Clinical Trials Research Associate - Urology

UIOWA • Iowa City, IA

22h • Hybrid

About The Position

The University of Iowa Healthcare, Department of Urology is seeking a full-time Clinical Trials Research Associate to design, plan, promote, and control clinical trials and coordinate the processing and analysis of trial data. The role supports protocol development and management, study operations, research and clinical activities, participant recruitment and enrollment, data collection and monitoring, regulatory compliance and documentation, and human resources and leadership. The position may be eligible for a hybrid arrangement within Iowa after the training period; work arrangement options will be discussed during hiring and are subject to university policies.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• At least 1 year of clinical research or related experience.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to manage complex information with attention to detail and a high level of accuracy.
• Proficiency in computer software applications.

Nice To Haves

• Prior experience with database software applications such as REDCap or BioShare.
• Knowledge of regulations, guidelines, and procedures that apply to human research.
• Prior experience with Institutional Review Board (IRB) application materials and processing.
• Experience in data collection and entry.
• Experience processing research regulatory documents.
• Knowledge of University of Iowa policies, procedures, and regulations.
• Prior experience in academic medicine, healthcare, or a research organization.
• Knowledge of urology and cancer research.

Responsibilities

• Assist with the design, development, execution, administration, and maintenance of protocols and clinical studies.
• Oversee case report form (CRF) development, review query reports, meet with study monitors, resolve monitoring issues, and develop complex research study materials.
• Initiate IRB submissions and renewals, communicate with constituents, and liaise with multi-center health care practitioners, agencies, and sponsors.
• Manage daily activities for assigned projects and coordinate clinical and data activities, study supplies, study visits, and trial-related procedures.
• Oversee participant recruitment; screen, recruit, enroll, and obtain informed consent from clinical trial participants, including recruiting through databases, EPIC, and provider clinics.
• Educate participants about study scope, potential risks and benefits, alternatives, and study requirements; relay information to the principal investigator and verify participant eligibility.
• Collect and document participant study activities.
• Participate in the design, development, and testing of clinical research data systems; validate data, resolve queries, recommend resolutions, and revise data collection processes.
• Perform data processing, including data entry and verification, identification of problematic data, and query generation; track study participant data.
• Manage and organize regulatory documentation from sites and regulatory authorities; prepare regulatory submissions and study start-up activities.
• Perform on-site audits of research and clinical data, monitor regulatory compliance and document maintenance, and recommend corrective action for reportable events when appropriate.
• May provide functional or administrative supervision and mentor new staff under direction.
• May develop and manage study budgets in coordination with Urology Research Administration.

What This Job Offers

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