Clinical Research Associate

Responsibilities

• Conduct site monitoring responsibilities for clinical trials
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Collaborate with Lead CRAs, Senior CRAs, in-house CRAs, Associate Director of Clinical Monitoring, and Project Managers
• Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics documents and site contract negotiation
• Provide monthly billing information to Finance
• Manage study budgets and act as sponsor referent for stand-alone monitoring projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate and timely monitoring visit reports
• Review and verify source documents and CRF data
• Perform quality control and verification of eTMF/TMF documents
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
• Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Collaborate with other CRAs to maintain consistency and teamwork
• Assist with CRA new hire training and onboarding
• Mentor CRAs
• Collaborate on development and maintenance of the Clinical Trial Management System (CTMS)
• Manage conflicting priorities and deliver on commitments
• Perform additional duties as assigned

Requirements EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Bachelor's degree in Biology or Life Sciences Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities Quality focused; careful, thorough, and detail-oriented Strong organizational skills; ability to multitask and work effectively in a fast-paced environment Ability to manage priorities, organize time, and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy, and disciplined Ability to problem-solve unstructured or ambiguous challenges Strong command of the local language, written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture Self-starter able to thrive in a collaborative, less structured team environment Knowledge of clinical research, ICH GCP, and local regulations Knowledge of regulatory and ethical requirements EU: Adequate English Core Competencies Demonstrates expertise in clinical trial monitoring, ensuring compliance with ICH GCP, FDA regulations, and company SOPs. Proficient in managing study budgets, conducting site visits, and providing leadership and guidance to CRA teams. Highest-signal resume keywords Clinical Trial Monitoring ICH GCP Compliance Study Budget Management Leadership Skills Clinical Trial Management System (CTMS) ATS Optimization Keywords Hard Skills Site Monitoring Protocol Compliance Quality Control Data Verification Adverse Event Reporting Investigator Site Visits Source Document Review Monitoring Plan Development Regulatory Binder Review Electronic Data Capture Soft Skills Organizational Skills Problem-Solving Interpersonal Skills Communication Skills Negotiation Skills Certifications & Qualifications Certified Monitor (Italy) Bachelor's Degree in Biology or Life Sciences Industry Keywords Clinical Research FDA Regulations Ethical Requirements Sponsor Relationships Cross-Functional Collaboration Tools & Technologies Clinical Trial Management Systems Clinical Trial Databases

ETMF/TMF

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