Clinical Trials Research Associate - Urology

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.