Clinical Trials Research Associate - Urology

UIOWA•Iowa City, IA

3d•Hybrid

About The Position

University of Iowa Healthcare’s Department of Urology seeks 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 position supports protocol development and management, research and clinical activities, subject recruitment and enrollment, data collection and monitoring, regulatory submissions and documentation, and human resources and leadership activities. The associate assists with designing, developing, executing, administering, and maintaining protocols and clinical studies; oversees case report form development and query reports; meets with study monitors and resolves monitoring issues; develops research materials; initiates IRB submissions and renewals; and coordinates with multicenter practitioners, agencies, and sponsors. The position manages assigned projects and supports clinical and data coordination, study visit preparation, and trial-related scheduling. It also oversees subject recruitment, screening, enrollment, informed consent, participant education, eligibility verification, and documentation of study activities. Responsibilities further include supporting clinical research data systems, validating and processing data, resolving queries, tracking participant data, organizing regulatory documentation, preparing submissions and study start-up activities, auditing research and clinical data, and monitoring regulatory compliance. The role may provide functional or administrative supervision, mentor new staff under direction, and develop and manage study budgets in coordination with Urology Research Administration. The position may be eligible for a hybrid arrangement within Iowa after completion of the training period. On-campus and remote work options will be discussed during hiring and are subject to annual review and applicable university policies. The position is not eligible for University sponsorship for employment authorization. Applicants must submit a resume and cover letter marked as “Relevant File.” Successful candidates will undergo criminal background and credential/education verification checks.

Requirements

A 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 in the design, development, execution, administration, and maintenance of protocols and clinical studies.
Oversee case report form development, review query reports, meet with study monitors, and resolve monitoring issues.
Develop complex research study materials and initiate IRB submissions, renewals, and communications with constituents.
Liaise with multicenter health care practitioners, agencies, and sponsors.
Manage the daily activities of assigned projects and coordinate clinical and data activities for research.
Set up supplies for study visits and schedule trial-related procedures.
Oversee subject recruitment, including mining databases and EPIC and recruiting from providers’ clinics.
Screen, recruit, and enroll participants; obtain informed consent; educate participants about study scope, risks, benefits, alternatives, and requirements; relay information to the principal investigator; and verify eligibility.
Collect and document participant study activities.
Participate in the design, development, and testing of clinical research trial data systems.
Validate data, resolve queries, recommend resolutions, revise and implement changes to data collection, and perform data processing tasks such as data entry, verification, and identification of problem data.
Track study participant data.
Manage and organize regulatory documentation from sites and regulatory authorities.
Prepare regulatory submissions and start-up activities for new studies.
Perform on-site audits of research and clinical data and monitor regulatory compliance and document maintenance.
May recommend corrective action for reportable events.
May provide functional and/or administrative supervision and mentor new staff under direction.
May develop and manage study budgets in coordination with Urology Research Administration.