Senior Clinical Research Associate(m/w/x)

Anforderungen

• BS/BA from an undergraduate program in life sciences or related discipline
• 3 years of experience in pharmaceutical/biotechnology/CRO industry
• 2 years of clinical monitoring experience
• 1 year of management experience
• Minimum 2 years of clinical monitoring experience
• Ability to autonomously manage monitoring activities
• Quality focused and detail-oriented
• Strong organizational skills
• Ability to multi-task and work effectively in a fast-paced environment
• Ability to manage priorities and solve problems
• Strong analytical, negotiation, and leadership skills
• Ability to travel
• Ability to manage stress
• Professional, trustworthy, and disciplined
• Ability to problem-solve unstructured challenges
• Strong command of English, both written and verbal
• Strong command of local language, both written and verbal
• Excellent communication and interpersonal skills
• Good computer skills with clinical trial management systems
• Self-starter who thrives in a collaborative environment
• Knowledge of clinical research, ICH GCP, and local regulations
• Knowledge of regulatory and ethical requirements
• Ability to establish and maintain positive relationships
• Permanent authorization to work in the U.S.
• Certified Monitor in compliance with Italian CRO decree
• Graduation in a scientific health field
• Adequate English
• Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy

Aufgaben

• Provide guidance and oversight to the CRA team
• Review monitoring visit reports
• Conduct co-monitoring and evaluation visits
• Ensure timely investigator site visits
• Coordinate with cross-functional departments for issue resolution
• Assist in developing study-specific Monitoring Plans
• Create training presentations as needed
• Set up and collect site-specific ethics documents
• Negotiate site contracts as required
• Provide monthly billing information to the finance team
• Manage study budget for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits
• Document monitoring visits accurately and timely
• Ensure integrity of CRF data through source document review
• Conduct quality control of documents for eTMF/TMF
• Account for investigational product
• Review site regulatory binder for required documents
• Maintain regular contact with study sites for compliance
• Assess patient accrual rates and respond to sponsor requests
• Ensure compliance with ICH GCP guidelines and FDA regulations
• Participate in internal and client meetings as required
• Facilitate adverse event reporting and reconcile SAE reports
• Resolve queries on discrepant data with in-house CRAs
• Identify site issues and develop problem-solving strategies
• Prepare for audits at study sites as needed
• Collaborate with other CRAs to promote team consistency
• Assist in CRA new hire training and onboarding
• Mentor junior CRAs
• Collaborate on the development of the Clinical Trial Management System
• Manage conflicting priorities to meet commitments
• Perform additional duties as assigned

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien