Seattle, Washington, United States
Experienced Clinical Project Manager with a demonstrated history of working in the biotechnology industry. Strong research professional skilled in Microsoft Word, Microsoft Excel, Data Analysis, Social Media, and Research.
Clinical Research Associate: Corbus Pharmaceuticals 1. The primary point of contact for investigator sites, and is responsible for ensuring the clinical trial is being conducted according to CFR, ICH guidelines and GCP. 2. Is responsible for the efficient execution of monitoring and other clinical trial management activities, tracks the progress of assigned studies/projects. Proactively identifies potential challenges and develops appropriate actions to resolve issues and achieve target objectives. • Performs investigator site pre-study site qualification visits including collection of site regulatory documents. • Assists with site start-up activities including: site contracts and budget development/negotiation, preparation of IRB submissions (including follow through to ensure successful outcome). • Ensures investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug. • Assists in the development of study/program plans (e.g., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.). • Manages patient recruitment strategies, or pro-actively identifies barriers to recruitment and propose solutions (e.g., study site webinars, newsletters, or other potential creative solutions). • Monitors recruitment, data quality, and patient safety while on site and remotely through EDC systems and direct site communication. • Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries. • Maintains project file. • Identifies and completes follow- up of SAEs at study sites. • Ensures appropriate and timely submission of documents to the Trial Master File.