Clinical Site Activation Professional
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Clinical research professional with over 7 years of experience in regulatory operations; study start-up, regulatory submissions, site activation, and document control. Expertise in maintaining awareness of regulatory legislation, compiling and preparing IRB/EC/Third body submissions, and ensuring compliance with ICH-GCP, SOPs, and regulatory standards. Adept at liaising with investigative sites, regulatory authorities, and internal stakeholders to meet project timelines and quality standards.
Proven ability to mentor and train junior team members while proactively identifying and mitigating risks in the start-up process. Strong knowledge of site contract negotiation, patient informed consent customization.
