Obtaining proper signatures on an Informed Consent Form (ICF) is the first step to starting research procedures. Failure to obtain adequate signatures on the ICF may result in audits from different organizations.
Large research institutions that are for profit sometimes require personnel that are able to negotiate and renegotiate contracts with sponsors. Such personnel must be able to match their institution’s overhead and the sponsor’s schedule of events for maximum profit.
Certain forms of advertisement can only be used after IRB approval. Advertisements designed to position a company as an authority in a particular indication cannot be regulated by an IRB however.
For those entering a research related company for the first time, it is important to focus on any knowledge about the field of research. One skill that is easily transferable into the research world is data management, which can be found in other areas such as marketing and business.
A Contract Research Organization’s (CRO’s) methods for choosing a quality Clinical Research Associate (CRA) are explored. Of primary importance is the individual’s understanding of what a CRA does as well as why.
The role of Clinical Research Associates (CRA’s) during events such as protocol deviations, adverse events, and Serious Adverse Events (SAE’s) is discussed. While CRA’s do not report these events, they are responsible for ensuring that the investigator successfully communicates to the Institutional Review Board (IRB).