University Of Iowa Clinical Trials Statistical And Data Management Center Work Values

Daily Duties at University Of Iowa Clinical Trials Statistical And Data Management Center:

Lead Regulatory Coordinator at CTSDMC (essentially an academic CRO). Worked with NIH on the multinational CIT Consortium. Developed Regulatory Binder tabs, instructions, and documents; received and reviewed documents submitted by participating sites; worked with CMC committee to develop MPBR and associated CRFs; worked with IT to develop web-based database for collection of eCRFs and to track collection of Clinical Study and Regulatory Documents from sites. Assisted NIH Regulatory Officer in creating submissions to FDA and Health Canada, and led CTSDMC Regulatory team in assembling and sending submissions to Health Authorities. Participated in Site Initiation Visits, including presentations on GCPs, IRBs, and Clinical Study and Regulatory Document collection and maintenance at sites. Collaboarted with CTSDMC Clinical team in developing CRFs to ensure that all relevant data needed for Annual Reports were collected and that data were being collected on only one CRF. Supervised one Regulatory Coordinator and one Regulatory Assistant.

What they like about University Of Iowa Clinical Trials Statistical And Data Management Center:

Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

Tags

Clinical Research Associate, CRA, Regulatory, Monitor, Auditor, GCPs

Skills

P&L responsibilities, Presentation, Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts., Technology Solutions, Sales Support, Software Implementation, Requirements Analysis & Specification, Leadership

These are some of the questions we asked our climbers about their experiences with University Of Iowa Clinical Trials Statistical And Data Management Center: