Denver, Colorado, United StatesIn addition to the CRC I experience described in UMMUNOe, as a CRC II I also: • Managed clinical trials from initiation to closeout, ensuring protocol adherence and patient safety.
• Collaborated with RNCs and PIs to review patient eligibility and source documents, enhancing study accuracy.
• Implemented strategies to improve protocol efficiency, resulting in more effective monitoring visits....
Denver, Colorado, United States• Liaised with FDA, NIH, and other regulatory bodies to ensure compliance and successful study coordination.
• Managed clinical trial processes from start-up to completion, ensuring timely data entry and resolution of queries.
• Developed tailored recruitment strategies for each study, enhancing participant engagement.
• Facilitated study procedures, including obtaining consent, processing sa...
Intensive Clinical Research Training covering Core Competencies including:
• ICH GCP E6 R2
• FDA Regulations 21 CFR Parts 11, 50, 54, 56
• Data Management Systems, Electronic Data Capture (EDC) systems; MedRio, Medidata, InForm
• Informed Consent Creation, Process, Execution
• Clinical Trial Operations from feasibility through close-out (Site and Sponsor/CRO responsibility and duties)
• GDP f...