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:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

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: