Sr Clinical Research Associate

Job Summary

Senior Chief Research Associate (Sr CRA) based in Italy, responsible for independent site monitoring, oversight, and management of clinical trials to ensure compliance with protocols, GCP, and sponsor requirements. Works closely with US and EU monitoring teams and project managers to support protocol adherence, site recruitment, training, and study progress.

Key Responsibilities

• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Review monitoring visit reports, conduct co‑monitoring and evaluation visits, and ensure timely investigator site visits.
• Coordinate with cross‑functional departments to negotiate/resolve monitoring related issues.
• Assist in development of study‑specific monitoring plans and training presentations.
• Set up/collect site‑specific ethics documents and negotiate site contracts.
• Provide monthly billing information to finance team and manage study budget for stand‑alone projects.
• Perform qualification, initiation, interim, and close‑out visits both remotely and onsite, ensuring proper documentation.
• Prepare accurate monitoring visit reports documenting site problems, resolutions, actions, protocol deviations, progress, and enrollment.
• Ensure integrity of CRF data through meticulous source document review and verification.
• Perform quality control and verification of documents collected at sites for eTMF/TMF.
• Conduct investigational product accountability and review site regulatory binder for required documents.
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual, and respond to sponsor requests.
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.
• Collaborate with in‑house CRAs/CTC and data management to resolve queries on discrepant data.
• Proactively identify site issues and develop problem‑solving strategies.
• Conduct audit preparation at study sites as needed.
• Assist in CRA new‑hire training, onboarding, and mentoring.
• Collaborate with development and maintenance of Clinical Trial Management System (CTMS).
• Manage and resolve conflicting priorities to deliver commitments and perform additional duties as assigned.

Desired Qualification & Experience

• US: BS/BA in life sciences or related discipline.
• US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience, and 1 year of management experience.
• EU (Italy): Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry with autonomy in monitoring activities.
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15 Nov 2011.
• EU (Italy): Graduation in a scientific health field and adequate English language skills.
• US: Permanent authorization to work in the U.S.; EU: A professional degree in science and local language proficiency.

Technical Competences & Soft Skills

• Attention to detail, quality‑focused, and thorough data review.
• Strong organizational skills with ability to multi‑task and work in a fast‑paced environment.
• Prioritization, time management, and problem‑solving skills.
• Strong analytical, negotiation, meeting management, cross‑functional teamwork, and leadership abilities.
• Ability to travel as required.
• Stress management and professional, trustworthy, disciplined demeanor.
• Excellent communication and interpersonal skills with a customer‑service orientation.
• Computer proficiency with clinical trial management systems, databases, and electronic data capture.
• Self‑starter thriving in a collaborative yet less structured team environment.
• Knowledge of clinical research, ICH GCP, local regulations, and regulatory/ethical requirements.
• Ability to establish and maintain positive relationships with sponsor, site, and project team members.