Clinical Research Associate I And Ii
Current• Uses sound judgment and experience to evaluate overall performance of site and site staff and provides recommendations regarding site-specific actions; immediately communicates and escalates serious issues to the project team and develops action plans with solid solutions that ensure high-quality standards• Identifies the best strategy to mitigate costs and risks, as well as the best sites for trials, and validates whether the protocol meets regulatory requirements, while evaluating the impact of competitive trials and optimizing patient access and retention• Leads communication between stakeholders and facilitates effective communications between team members and external partners, as critical milestones are monitored, and corrective action plans are created and implemented• Ensures Federal, local, FDA, IRB, and HIPAA guidelines are followed to deliver exceptional patient care and clinical research practices, as well as company standard operating procedures and clinical monitoring plans • Spearheads the analysis of site qualification, site initiation, interim monitoring, site management activities and close-out visits• Advises, mentors, coaches, and guides various levels of personnel to encourage positive engagement and leadership, building lasting relationships, as well as credibility and trust• Reviews ISF for accuracy, timeliness and completeness while reconciling contents for the TMFLeadership, Strategic Business Planning, Risk Management, Critical Thinking, Networking, Program Management, Process Improvement, Complex Problem Solving, Empathy, Public Speaking, Compelling Communicator, Customer Experience, People’s Advocate, Basic Lean Methodologies, Compliance, Adaptability, Inventory Management and Reconciliation, Team Performance Optimization, Data Analysis, Resource Management, Research Development, Good Clinical Practice, Electronic Medical Records (EMR), Project Management
