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:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

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: