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Sponsor Dedicated Cra Ii/Sr Cra I - Home Based Ita

2+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: Sponsor Dedicated CRA II/Sr CRA I - Home Based ITA

Company: Syneos Health
Location: Home-Based, Italy (Preference: Milan area)
Job ID: 25003314
Updated: April 23, 2025


About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by combining deep clinical, medical affairs, and commercial expertise. With a team of 29,000 employees in 110 countries, we center our work around both the customer and patient to improve outcomes in an ever-evolving market.


Why Join Us:

  • Career development and growth opportunities

  • Strong line management and peer recognition

  • Total rewards program

  • Inclusive and diverse “Total Self” culture


Job Role Overview:
As a Sponsor Dedicated CRA II/Sr CRA I, you will monitor and manage clinical trial sites to ensure protocol, ICH-GCP, and regulatory compliance. This is a home-based role requiring up to 75% travel, ideally based around the Milan area.


Key Responsibilities:

  • Conduct on-site and remote site qualification, initiation, monitoring, and close-out visits

  • Ensure proper documentation and compliance with informed consent processes

  • Identify, report, and escalate protocol deviations and patient safety issues

  • Perform source document verification and data accuracy checks

  • Guide and resolve queries with site staff

  • Support investigational product (IP) management including storage, dispensing, and accountability

  • Maintain and reconcile Investigator Site Files (ISF) and Trial Master Files (TMF)

  • Ensure audit readiness and assist with audit follow-ups

  • Enter site data in tracking systems and maintain comprehensive documentation

  • May serve as liaison with site personnel and lead CRA/project staff meetings

  • Provide training or mentorship to junior CRA staff


Additional Responsibilities (for Real World Late Phase - RWLP):

  • Support all phases from site identification to close-out

  • Execute chart abstraction and data collection

  • Develop country-specific informed consent forms

  • Collaborate with sponsor, medical liaisons, and RWLP Regulatory team

  • Attend bid defense meetings and suggest operational improvements


Required Qualifications:

  • Minimum of 2 years as certified CRA (as per D.M. 15 Nov 2011)

  • Sound knowledge of ICH-GCP and other relevant regulations

  • Proficient with digital tools and data systems

  • Excellent interpersonal, presentation, and communication skills

  • Ability to travel up to 75% as needed


Note:
This job description may evolve over time. Equivalent education, experience, or skills may be considered. Syneos Health is an equal opportunity employer committed to compliance with all applicable laws, including the Americans with Disabilities Act and EU Equality Directive.