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:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

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: