Senior Cra

Thermo Fisher Scientific

3+ years

Not Disclosed

Remote

10 Nov. 3, 2025

Job Description

Job Type: Full Time 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

Position: Senior Clinical Research Associate (Senior CRA)

Location: Remote – Italy (Milan, Bologna, Florence, Rome, Naples)
Job ID: R-01225634
Job Type: Full-time
Category: Clinical Research
Company: PPD – Part of Thermo Fisher Scientific
Work Schedule: Flexible / Other
Work Environment: Office / Fully Remote

About the Company

At PPD, part of Thermo Fisher Scientific, we are dedicated to making a positive global impact through research, development, and delivery of life-changing therapies. Our mission—to make the world healthier, cleaner, and safer—guides everything we do. With clinical trials conducted in over 100 countries, we’re at the forefront of advancing innovative clinical research through laboratory, digital, and decentralized trial services.

Join a team where your determination for quality, accuracy, and patient impact helps bring new therapies to life.

Position Overview

This is an excellent opportunity for experienced Senior CRAs from the life sciences sector—pharmaceuticals, biotech, or CROs—to join a world-leading contract research organization. You will work across multiple sponsors, protocols, and therapeutic areas, contributing to the delivery of high-quality clinical trials.

This role is fully remote, with national travel across Italy required.

Key Responsibilities

Monitoring & Site Management

Conduct monitoring visits using a risk-based monitoring approach.
Apply root cause analysis (RCA), critical thinking, and problem-solving to identify and resolve site process deficiencies.
Ensure data accuracy through SDR, SDV, and CRF reviews via on-site and remote monitoring.
Assess investigational product (IP) accountability through inventory checks and documentation reviews.
Perform site initiation, routine, and close-out visits in accordance with ICH-GCP and regulatory guidelines.
Ensure essential documents are complete, accurate, and compliant.
Maintain proactive communication with sites between visits to ensure protocol adherence and timely data entry.

Documentation & Reporting

Prepare monitoring reports, follow-up letters, and documentation using approved business writing standards and timelines.
Provide study status updates and progress reports to the Clinical Team Manager (CTM).
Ensure all relevant systems (e.g., Clinical Trial Management System) are updated as per study requirements.
Participate in investigator meetings and contribute to project tools, publications, and process improvements.

Collaboration & Issue Resolution

Escalate site deficiencies and work with project team members to implement corrective and preventive actions.
Collaborate with investigators to identify and qualify suitable trial sites.
Participate in investigator payment processes and follow-up on findings to resolution.
Support cross-functional teams in achieving clinical milestones efficiently.

Education & Experience

Bachelor’s degree (or higher) in a life science-related field.
CRA qualification as per the Ministerial Decree (15/11/2011).
Minimum 3 years of independent monitoring experience in clinical phases II–IV.
Sound understanding of ICH-GCP, EU, and FDA regulatory requirements.
Fluency in English and Italian (written and spoken).
Valid driver’s license (national travel required).

Knowledge, Skills & Abilities

Proven expertise in clinical monitoring and therapeutic area knowledge.
Strong command of medical terminology and GCP/regulatory compliance.
Advanced critical thinking and root cause analysis abilities.
Experience with Risk-Based Monitoring (RBM) processes.
Excellent oral and written communication and interpersonal skills.
Strong organizational and time management skills.
High attention to detail and ability to manage multiple tasks simultaneously.
Ability to work independently or collaboratively within a team.
Proficiency in Microsoft Office and ability to learn new clinical software tools quickly.
Flexibility and adaptability in a dynamic, fast-paced research environment.

What We Offer

Competitive salary and an extensive benefits package supporting employee health and well-being.
A flexible work culture that values work-life balance.
A collaborative global environment with local team spirit.
Continuous career development opportunities with industry experts.

Our Core Values – The 4i’s

Integrity – Do the right thing.
Innovation – Drive scientific and operational progress.
Intensity – Be passionate and results-oriented.
Involvement – Work together as one team.

Equal Opportunity Statement

PPD, part of Thermo Fisher Scientific, is an Equal Opportunity/Affirmative Action Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected characteristic.

Join Us

If you embody our 4i Values and want to accelerate the delivery of safe and effective therapeutics, apply now — we’d love to hear from you.

Apply Today: jobs.thermofisher.com

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Senior Cra

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