Clinical Research

• Support all phases of clinical research including planning, implementation, completion, and final reports of clinical trials.
• Serve as primary study team contact to manage study start-up, conduct, and close-out.
• Lead cross-functional study execution team to meet project milestones, budgets, and compliance with ICH/GCP and local regulatory authorities.
• Develop, plan, and forecast budget requirements for clinical programs and study sites.
• Manage CRO and vendor evaluation, selection, training, and oversight.
• Facilitate site feasibility and selection processes; conduct sponsor quality monitoring/oversight visits as needed.
• Provide strategic and operational input into study documents (protocol, ICF, CRFs, pharmacy and laboratory manuals).
• Oversight of preparation and submission of safety reports (pharmacovigilance).
• Forecast and manage investigational drug labeling, packaging and distribution; supply chain management.
• Ensure clinical record keeping in preparation for audits and inspections.
• Identify and engage thought leaders, investigators, cooperative groups, and other experts for study design and interpretation.
• In conjunction with data management, assist with eDC development, data listings, issue and query resolution.
• Collaborate on development and set-up of study systems (IVRS/IWRS, site payments and CTMS).
• Develop and report key executional metrics for oversight of clinical trials.
• Assist with creating, reviewing and implementing SOPs and processes in clinical development.
• Ensure documentation is prepared for inclusion in regulatory product submissions.

Senior Clinical Trial Manager

Clinical Research Intern

Head and Neck Clinical Research Coordinator

Biostatistician

Senior Clinical Scientist, GIS

Clinical Research Coordinator I – Non RN