Independent Research Consultant
CurrentExperienced Medical Writer in developing Draft Consent forms from Research Protocols (drugs, biologics, medical devices), outlining all of the required informed consent form elements and Sponsor/Site requested language. In writing the Draft Consent form, any issues noted in the process is brought to the attention of the Site/Sponsor/CRO, so these issues can be addressed prior to IRB submission. Experienced and Qualified IRB Board Member currently participating in IRB meetings in the review and approval of all phases of drug research and medical devices.