Clinical Trials Research Associate - Urology

UIOWA•Iowa City, IA

4d•Hybrid

About The Position

University of Iowa Healthcare, Department of Urology seeks to hire a full-time Clinical Trials Research Associate to design, plan, promote and control clinical trials and coordinate the processing and analysis of trials data. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines, documents and submission; and human resources/leadership. Position Responsibilities: Protocol Development/Management and Study Responsibilities: Assist in the design, development, execution, administration and maintenance of protocols and clinical studies. Oversee CRF development Review query reports. Meet with study monitor. Resolve all monitoring issues. Develop complex research study materials. Initiate IRB submissions, renewals and communication with constituents. Liaise with multi-center health care practitioners, agencies and sponsors. Research/Clinical Activities: Subject Recruitment and Enrollment: Responsible for the management and daily activities associated with the assigned projects. Assist with clinical and data coordination for research activities and set up supplies for study visits and schedule trial-related procedures. Oversee the recruitment of subjects. Screen, recruit enroll and obtain informed consent for clinical trials. Oversee the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics. Educate study participants on scope of study, potential risks and benefits, possible alternatives and study requirements. Relay information to principal investigator and verify study participant eligibility. Collect and document participant study activities. Data Collection and Monitoring: Participate in the design, development and testing of clinical research trials data systems. Validate data, query resolution and make recommendation for resolution. Revise and implement change in data collection. Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc. Track study participant data. Regulatory Guidelines and Documents: 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. Monitor compliance of regulatory guidelines and proper maintenance of documents. May recommend corrective action for reportable events. Human Resources/Leadership: May provide functional and/or administrative supervision. Mentor new staff under direction. Financial Responsibility: May develop and manage budget for studies in coordination with Urology Research Administration.

Requirements

A Bachelor’s degree or an equivalent combination of education and experience is required.
Minimum 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.
Proficient in computer software applications.

Nice To Haves

Prior experience in database software applications (RedCap, BioShare, etc.).
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 in processing research regulatory documents.
Knowledge of University of Iowa policies, procedures and regulations.
Prior experience in academic medicine, healthcare, or research organization
Knowledge of urology and cancer research.

Responsibilities

Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
Oversee CRF development
Review query reports.
Meet with study monitor.
Resolve all monitoring issues.
Develop complex research study materials.
Initiate IRB submissions, renewals and communication with constituents.
Liaise with multi-center health care practitioners, agencies and sponsors.
Responsible for the management and daily activities associated with the assigned projects.
Assist with clinical and data coordination for research activities and set up supplies for study visits and schedule trial-related procedures.
Oversee the recruitment of subjects.
Screen, recruit enroll and obtain informed consent for clinical trials.
Oversee the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics.
Educate study participants on scope of study, potential risks and benefits, possible alternatives and study requirements.
Relay information to principal investigator and verify study participant eligibility.
Collect and document participant study activities.
Participate in the design, development and testing of clinical research trials data systems.
Validate data, query resolution and make recommendation for resolution.
Revise and implement change in data collection.
Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc.
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.
Monitor compliance of regulatory guidelines and proper maintenance of documents.
May recommend corrective action for reportable events.
May provide functional and/or administrative supervision.
Mentor new staff under direction.
May develop and manage budget for studies in coordination with Urology Research Administration.