Beschreibung

As a Senior Clinical Research Associate, you will play a vital role in overseeing clinical trials, ensuring compliance, and providing guidance to the CRA team. Daily tasks will involve site monitoring, problem-solving, and collaborating with various departments to support study success.

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

Tools & Technologien