Indianapolis, Indiana, United States
Extensive experience in pharmaceutical clinical research and patient education. Skilled in managing site initiation, monitoring, and close-out visits in accordance with the contracted scope of work and good clinical practice. Support work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Build awareness of features and opportunities of study to site. • Collaborate and liaise with study team members for project execution support as appropriate
• Collaborates with study team members to ensure adherence to study protocols and regulatory requirements. • Assists in the management and coordination of study-related documents, including informed consent forms, case report forms, and regulatory submissions. • Assists in the preparation of study protocols, amendments, and other study-related documents. • Assists in the preparation and distribution of study supplies and materials to study sites. • Participates in study meetings and provides updates on study progress and issues. • Assists in the preparation and submission of study reports to regulatory agencies and sponsors. • Assists in the training and education of study site personnel on study protocols and procedures. • Assists in the coordination of study-related meetings and events. • Assists in the coordination of study-related travel arrangements for study team members. • Assists in the management and reconciliation of study-related budgets and expenses. • Assists in the resolution of study-related issues and conflicts. • Assists in the preparation and submission of study-related datasets to data management and analysis teams. • Assists in the review and analysis of study data to ensure accuracy and quality. • Assists in the preparation and presentation of study findings to internal and external stakeholders. • Assists in the development and maintenance of study databases and data management systems. • Assists in the coordination and implementation of study-related quality assurance and quality control activities. • Assists in the development and implementation of study-related performance metrics and indicators. • Assists in the monitoring and oversight of study site activities to ensure compliance with study protocols and regulatory requirements. • Assists in the management and tracking of study-related adverse events and serious adverse events.
This course provided an overview of the drug development process, from the initial discovery to new drug marketing/advertising. The course included preclinical studies, clinical trial design, marketing, and post-marketing procedures. The course was integrated with a semester-long class project. Course topics: Drug Discovery, Drug Development, INDA, Clinical Trial Overview, Phase I, II, III, IV, NDA, Health Economics, PRA, Drug Devices, Medical Affairs, and Global Public Policy.
• Educate HIV patients on viral loads, CD4 count, drug-drug interactions, and prevention of transmission of the disease. • Prepare daily case presentations to pharmacists. • Interact within a multidisciplinary team of doctors, nurses, and case managers.