_{20th October, 2025}

Clinical Research Associate - Phase II - IV
  
Location: Remote / EU / UK
Therapeutic Areas: Oncology & Rare Disease

About the Role
  
KEMIO Consulting is excited to be partnering with a medium-sized well-established CRO looking to expand their Clinical Research team. The Clinical Research Associate will support the delivery of clinical studies by monitoring study sites, ensuring data quality, and maintaining compliance with study protocols and regulatory requirements. Working under the guidance of the Head of Clinical Operations, this role provides hands-on exposure to clinical site management across start-up, maintenance, and close-out activities.
  
Key Responsibilities

• Support development and ongoing maintenance of Study Monitoring Plans (CMPs).
• Track site activities, documentation and source data verification (SDV) in CTMS/eTMF.
• Assist site staff (PIs, study coordinators) with training, documentation and query resolution.
• Ensure protocol, GCP/GPP and SOP compliance at assigned sites.
• Collaborate with data management on issue resolution and site query tracking.
• Support IRB/EC submissions and ensure consent forms remain current.
• Contribute to study team meetings and communication updates.
• Participate in audit/inspection readiness activities as needed.

Required Skills & Experience

• 3+ years of experience in clinical research, site management and clinical monitoring
• Experience working across Phase II - IV oncology or rare disease studies
• Understanding of ICH, GCP, GPP, HIPAA, GPDR and regulatory requirements for clinical studies
• Familiarity with CTMS and eTMF systems preferred.
• Strong attention to detail and documentation accuracy.
• Excellent communication and site relationship-building skills.
• Ability to manage time and tasks across multiple studies.

  
What We’re Looking For
  
A motivated early-career Clinical Research Associate with a passion for high-quality study delivery, strong organisational skills, and a collaborative mindset. This is an excellent role for individuals looking to grow into a fully independent CRA role with increasing site management and clinical monitoring responsibilities.

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