Job Description

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.

• 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.

• 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.

• 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 Otolaryngology Research Administration.
• Participate in invoice preparation for industry-sponsored studies.

Required Qualifications

• A Bachelor’s degree or an equivalent combination of education and experience is required.
• Minimum one year experience in clinical research.
• Knowledge of regulations, guidelines and procedures that apply to human research.
• Prior experience with Institutional Review Board (IRB) application materials and processing.
• Excellent written, verbal and interpersonal communication skills.
• Experience in coordinating multiple projects and diverse functions independently.
• Proficiency with computers, software and database systems.

• Knowledge of University of Iowa policies, procedures and regulations.
• Experience with following specific protocol techniques and management.
• Experience working in an academic research institution.
• Knowledge of otolaryngology and cancer research.

Position and Application Details

In

Successful candidates will be subject to a criminal background check and education/credential verification. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check. Up to 5 professional references will be requested at a later step in the recruitment process. In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:

• Resume
• Cover Letter

Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.

For additional questions, please contact Lydia Messer at lydia-messer@uiowa.edu

Benefits Highlights

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
• The University of Iowa offers a generous benefits package, including paid vacation and paid sick leave. Complete information regarding the full benefits package may be viewed at: Benefits | University Human Resources - The University of Iowa (uiowa.edu)

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