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Clinical Research Associate II - Job Opportunity at IQVIA

Dublin, Ireland
Full-time
Mid-level
Posted: June 12, 2025
Hybrid
EUR 45,000 - 55,000 per year based on mid-level CRA II position in Dublin market with oncology specialization

Key Responsibilities

Execute comprehensive site monitoring programs across Ireland and UK markets, ensuring adherence to Good Clinical Practice standards while driving operational excellence in oncology clinical trials
Lead strategic subject recruitment initiatives by collaborating with site teams to develop, implement, and optimize enrollment strategies that align with project timelines and enhance study predictability
Deliver protocol training and establish robust communication frameworks with assigned sites to manage expectations, resolve issues proactively, and ensure consistent study execution
Conduct quality assessments of study site operations, evaluating compliance with protocol requirements and regulatory standards while implementing corrective actions to maintain data integrity
Oversee comprehensive study progress management including regulatory submissions tracking, enrollment monitoring, CRF completion oversight, and data query resolution to ensure project milestones are met
Maintain meticulous documentation standards for Trial Master Files and Investigator Site Files, ensuring compliance with GCP and local regulatory requirements while supporting audit readiness
Generate detailed monitoring reports, visit summaries, and follow-up correspondence that provide actionable insights for study team decision-making and regulatory compliance
Foster cross-functional collaboration with study team members to optimize project execution and deliver integrated support across all phases of clinical trial management

Requirements

Education

Life science degree educated or equivalent industry experience

Experience

Experience of independent on-site monitoring (2 years +) on Oncology studies

Required Skills

In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
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Sauge AI Market Intelligence

Industry Trends

The clinical research industry is experiencing unprecedented growth driven by the acceleration of oncology drug development, with cancer therapeutics representing the largest segment of the pharmaceutical pipeline. This growth is fueled by advances in precision medicine, immunotherapy, and personalized treatment approaches, creating sustained demand for experienced Clinical Research Associates specializing in oncology studies. Digital transformation in clinical trials is reshaping the CRA role, with increasing adoption of remote monitoring technologies, electronic data capture systems, and risk-based monitoring approaches. CRAs are expected to be proficient in digital platforms while maintaining traditional site relationship management skills. Regulatory complexity continues to increase globally, particularly in oncology trials involving novel therapeutic modalities. CRAs must navigate evolving regulatory landscapes while ensuring compliance with Good Clinical Practice standards across multiple jurisdictions. The shift toward patient-centric trial designs and decentralized clinical trials is creating new opportunities for CRAs who can adapt to hybrid monitoring models and support innovative study execution approaches.

Role Significance

Typically manages 8-12 clinical sites independently while collaborating within a study team of 15-25 professionals including project managers, data managers, biostatisticians, and medical monitors
Mid-level professional role with independent site management responsibilities and potential for mentoring junior staff. The CRA II designation indicates advancement beyond entry-level with proven competency in complex oncology studies.

Key Projects

Phase II and III oncology clinical trials for novel cancer therapeutics including immunotherapies, targeted therapies, and combination treatments Multi-center international studies requiring coordination across diverse regulatory environments and healthcare systems Adaptive trial designs incorporating interim analyses and protocol modifications based on emerging efficacy and safety data Investigator-sponsored trials and academic collaborations focused on translational oncology research

Success Factors

Deep therapeutic area expertise in oncology combined with strong understanding of cancer biology, treatment protocols, and patient populations to effectively communicate with principal investigators and site staff Exceptional relationship management skills to build trust with site personnel, navigate complex healthcare systems, and maintain productive partnerships across diverse cultural and regulatory environments Analytical mindset with attention to detail for identifying data quality issues, protocol deviations, and regulatory compliance gaps while implementing effective corrective and preventive actions Adaptability and resilience to manage competing priorities, travel demands, and the emotional challenges associated with working in oncology research where patient outcomes carry significant weight

Market Demand

High demand driven by robust oncology pipeline, regulatory complexity, and shortage of experienced CRAs with specialized therapeutic area knowledge

Important Skills

Critical Skills

Good Clinical Practice (GCP) expertise is fundamental as it provides the regulatory framework governing all clinical research activities and ensures patient safety, data integrity, and study validity Oncology therapeutic area knowledge is essential for effective communication with investigators, understanding of complex protocols, and recognition of clinically significant safety signals in cancer patients Independent site monitoring capabilities are crucial as this role requires autonomous decision-making, problem-solving, and relationship management across multiple clinical sites

Beneficial Skills

Digital monitoring platform proficiency to leverage emerging technologies for remote oversight and data review Cross-cultural communication skills to effectively work with diverse site teams across Ireland and UK markets Project management capabilities to coordinate multiple competing priorities and support overall study execution Regulatory affairs knowledge to navigate evolving compliance requirements and support regulatory submission activities

Unique Aspects

Dedicated sponsor relationship model providing continuity and deep partnership with specific pharmaceutical clients
Focus on oncology therapeutic area offering specialized career development in one of the most dynamic and impactful areas of medical research
Geographic coverage spanning Ireland and UK markets providing exposure to diverse regulatory environments and healthcare systems
Integration with IQVIA's broader analytics and commercial capabilities offering unique insights into drug development lifecycle

Career Growth

Progression to senior CRA level typically occurs within 2-3 years with demonstrated performance, while transition to management roles generally requires 4-6 years of progressive experience

Potential Next Roles

Senior Clinical Research Associate with expanded site portfolio and mentoring responsibilities Lead CRA or CRA Manager overseeing team of junior and mid-level CRAs Clinical Project Manager transitioning to overall study management and cross-functional leadership Therapeutic Area Specialist focusing on oncology with consultative responsibilities across multiple studies

Company Overview

IQVIA

IQVIA is a global leader in clinical research services and healthcare analytics, formed through the merger of IMS Health and Quintiles. The company operates as one of the world's largest contract research organizations with comprehensive capabilities spanning clinical development, regulatory affairs, and commercial insights.

Market leader in clinical research services with strong presence in oncology trials and established relationships with major pharmaceutical and biotechnology companies worldwide
IQVIA maintains significant operations in Ireland and the UK, serving as a strategic hub for European clinical research activities with access to diverse patient populations and well-developed healthcare infrastructure
Professional services environment emphasizing scientific rigor, client service excellence, and career development opportunities within a global organization offering exposure to cutting-edge therapeutic developments
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