Brandon Pickens

Regulatory Affairs Coordinator @Wellstar Health System

Prepared study-specific documents, such as protocols, informed consents, and review and response letters for submission to the Institutional Review Board (IRB)\\\\n Participated in site monitoring visits (SIV) with pharmaceutical sponsors\\\\n Reviewed new regulatory guidance and regulations, evaluating its potential impact on projects, and advising study team personnel regarding applicability and impact\\\\n Solicited staff input in the development of action plans to address areas of inefficiency\\\\n Communicated with Local, State, and Federal agencies, as it pertained to contracts, while being in frequent correspondence with sponsor, CRO, IRB, FDA and other local and Federal agencies\\\\n Responded and fulfilled requests for written summaries and documents\\\\n Coordinated pre-site visit by scheduling with appropriate department Report SAEs and protocol deviations to the IRB as required\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n