The Department of Otolaryngology - Head and Neck Surgery at The University of Iowa Hospitals and Clinics is seeking a 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.
Duties to include:
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 coordinating with scheduling team to 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: dates, study components completed, etc.
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 Otolaryngology Research Administration.
• Participate in invoice preparation for industry-sponsored studies.
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