Senior Cra

Thermo Fisher Scientific

0-2 years

Not Disclosed

Remote

10 Nov. 3, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Clinical Research Associate (Senior CRA)

Job ID: R-01225634
Job Type: Full-Time
Category: Clinical Research
Location: Fully Remote (Italy)
Available in: Milan, Bologna, Florence, Rome, Naples
Work Schedule: Other
Environment: Office / Remote

Company Overview

PPD, part of Thermo Fisher Scientific, is a global leader in clinical research services, driving innovation in drug development and delivery of life-changing therapies. With trials conducted in over 100 countries, PPD empowers its teams to make a global impact by enabling customers to make the world healthier, cleaner, and safer.

This role provides an excellent opportunity for experienced Senior Clinical Research Associates from pharmaceutical, biotech, or CRO backgrounds to work across multiple sponsors, protocols, and therapeutic areas.

Position Summary

The Senior CRA will perform clinical monitoring activities in compliance with ICH-GCP guidelines, sponsor protocols, and regulatory requirements. The role involves remote and on-site monitoring, ensuring high data quality, patient safety, and overall site compliance across clinical studies conducted nationally within Italy.

Key Responsibilities

Monitoring and Site Management

Conduct site monitoring visits using a risk-based monitoring approach.
Apply Root Cause Analysis (RCA), critical thinking, and problem-solving to identify and correct site process issues.
Perform Source Data Review (SDR), Source Data Verification (SDV), and CRF reviews through remote and on-site activities.
Verify investigational product (IP) compliance via physical inventory and record reviews.
Document findings in reports and follow-up letters within required timelines and quality standards.
Maintain consistent communication with investigative sites to ensure protocol adherence and timely data entry.

Compliance and Quality

Escalate site deficiencies and ensure resolution through corrective and preventive actions (CAPA).
Ensure that essential regulatory documents are complete, current, and compliant with ICH-GCP and applicable regulations.
Conduct on-site file reviews per project specifications.

Project Coordination

Participate in investigator identification, site initiation, and study close-out activities.
Contribute to investigator meetings and study-specific trainings.
Collaborate with project teams to resolve issues and ensure smooth trial execution.
Track trial progress and update study management systems (e.g., Clinical Trial Management System – CTMS).
Support project-related publications, tools, and process improvement initiatives.

Financial Oversight

Participate in the investigator payment process and coordinate issue resolution related to site payments.

Education and Experience

Bachelor’s degree (or higher) in a science-related field.
CRA qualification as per the Italian Ministerial Decree (15/11/2011).
Minimum 3 years of independent monitoring experience in clinical development (Phases II–IV).
Strong understanding of ICH-GCP, EU, and FDA regulations.
Fluent in English and Italian.
Valid driver’s license required.

Knowledge, Skills, and Abilities

Proven expertise in clinical monitoring and site management.
Solid understanding of medical and therapeutic area terminology.
Strong critical thinking and root cause analysis skills.
Proficiency in Risk-Based Monitoring (RBM) principles.
Excellent written and verbal communication skills with healthcare professionals.
Exceptional organizational and time management skills.
Strong interpersonal abilities and team collaboration mindset.
Detail-oriented, adaptable, and capable of working independently.
Proficient in Microsoft Office Suite and capable of learning specialized software tools.

Compensation and Benefits

Competitive salary and comprehensive benefits package focused on employee well-being.
Flexible working culture supporting work-life balance.
Collaborative global environment with strong local team support.

Core Values – The 4i Principles

Integrity – Innovation – Intensity – Involvement

These values define how PPD operates, collaborates, and innovates to accelerate the delivery of safe, effective therapeutics addressing the world’s most urgent health challenges.

Why Join Us

Join PPD and become part of a passionate team committed to advancing clinical research and improving global health outcomes. If you share our dedication to excellence and innovation, we’d love to hear from you.

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Senior Cra

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