University Of Colorado Cancer Center Work Values

Daily Duties at University Of Colorado Cancer Center:

Used knowledge of GCP, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions in relation to conducting multiple clinical research trials with adherence to all research standards as set forth by the FDA, Office of Human Research Protection (OHRP), University of Colorado Hospital, Health Sciences Center, NCI and other pertinent regulatory agencies. Served as regulatory contact person for ongoing clinical research studies and meet with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records. Submitted complete clinical research applications to all required reviewers. Maintained continuous communication with regulatory committees and sponsors prior to and during the protocol development and approval process, and ensured proper communication and follow up. Wrote clear and accurate emergency use applications to the FDA, subject informed consent documents and HIPAA authorizations. Prepared and submitted amendments and revisions from sponsors and investigators to the respective review boards.

What they like about University Of Colorado Cancer Center:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

professional, CRA, regulatory, research, clinical, medical writing

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 , Content authoring

These are some of the questions we asked our climbers about their experiences with University Of Colorado Cancer Center: