Clinical Research Associate

• May 2023 - Present

Clinical Research Associate

• Nov 2021 - Present

• Perform site initiation visits as per monitoring plan. Initiation visits to include pharmacy and other facilities as needed to confirm delivery of study material, documents, products and to ensure investigational team understands protocol, SOPs and GCP requirements and that that facilities, including laboratories, equipment, and staff, are adequate to conduct trial safely and properly and remain adequate throughout trail period. • Lead development and maintenance of clinical study timelines and clinical trial risk identification and management. • Lead development and review of Clinical Protocols, ICFs, CRFs, SOPs and other trial related documents. • Provide written site initiation report and site follow up letter and SIV report approved time frame. Ensure data quality as defined in quality management plan(s)/operational documents. • Conduct and document Sponsor-level oversight or monitoring visits, as needed •Plan and coordinate site audits, including defining, scheduling, assessing, and evaluating eventual outcomes and supporting remedial plans. • Perform Routine monitoring visits ensure that studies are conducted according to protocol, SOP, GCP and other applicable regulations to ensure safety of participants and quality of data. • Lead study-specific meetings (including development of agendas, minutes, action items, and decisions) and maintain study-related documentation. Show less