Single Sponsor Senior CRA II – Oncology (UK-Based)
Updated: February 3, 2026
Location: London, United Kingdom (UK-Based)
Job ID: 25104935
Employment Type: Full-Time
Functional Area: Clinical Monitoring / Oncology Clinical Trials
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating the delivery of innovative therapies worldwide. By combining clinical development, medical affairs, and commercial expertise, Syneos Health partners with sponsors to translate insights into measurable outcomes. With approximately 29,000 employees across more than 110 countries, Syneos Health is recognized for its commitment to quality, operational excellence, and patient-centric clinical research.
Role Overview
The Single Sponsor Senior CRA II – Oncology is responsible for independently managing and monitoring oncology clinical trials within the United Kingdom. This role supports a dedicated sponsor model and requires strong experience in UK on-site monitoring and risk-based monitoring (RBM). The position plays a critical role in ensuring subject safety, data integrity, regulatory compliance, and high-quality trial execution across assigned sites.
Key Responsibilities
Clinical Monitoring & Compliance
Perform on-site and remote monitoring visits (qualification, initiation, interim, and close-out) in accordance with study protocols, ICH-GCP, SOPs, and UK regulatory requirements.
Execute risk-based monitoring strategies, including proactive identification and mitigation of site-level risks impacting patient safety and data quality.
Verify informed consent processes, subject safety, and confidentiality in compliance with regulatory and ethical standards.
Data Quality & Documentation
Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure accuracy, completeness, and consistency of clinical trial data.
Review Investigator Site Files (ISF) and reconcile documentation with the Trial Master File (TMF).
Ensure investigational product (IP) accountability, storage, reconciliation, and compliance with protocol requirements.
Prepare accurate monitoring reports, follow-up letters, and communication logs within defined timelines.
Site & Stakeholder Management
Act as the primary liaison between the sponsor and investigative sites, maintaining effective communication and strong site relationships.
Evaluate site performance and provide recommendations for corrective and preventive actions (CAPA).
Escalate significant quality, compliance, or safety issues to the project team in a timely manner.
Leadership & Mentorship
Provide guidance, training, and mentorship to junior CRAs to support professional development and monitoring excellence.
Support audit and inspection readiness activities at the site and project level.
Contribute to the continuous improvement of monitoring processes, tools, and templates.
Required Qualifications & Experience
Education
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
Equivalent education, training, or experience may be considered.
Experience
Minimum 5–7 years of clinical research experience, including significant experience as a Clinical Research Associate.
Proven experience in oncology clinical trials within a single sponsor or sponsor-dedicated model.
Mandatory experience in UK-based on-site monitoring.
Demonstrated hands-on experience with risk-based monitoring (RBM) methodologies.
Technical & Regulatory Knowledge
Strong working knowledge of ICH-GCP, UK regulatory requirements, and clinical trial conduct.
Experience using clinical trial systems such as CTMS, EDC, eTMF, and related monitoring tools.
Skills & Competencies
Excellent analytical, problem-solving, and organizational skills.
Strong written and verbal communication abilities.
Ability to work independently while effectively collaborating within cross-functional teams.
Capability to manage multiple sites and priorities in a fast-paced clinical research environment.
Certifications (Preferred)
Certified Clinical Research Professional (CCRP) or equivalent certification is preferred.
Why Join Syneos Health
Work within a dedicated single sponsor model on high-impact oncology trials.
Structured career development, technical training, and leadership support.
Supportive and inclusive culture focused on collaboration and professional growth.
Exposure to globally recognized sponsors and innovative oncology pipelines.
Competitive total rewards and employee recognition programs.
Additional Information
This job description is not exhaustive and may be modified based on business needs. Syneos Health is an equal opportunity employer and complies with all applicable employment and equality legislation. Reasonable accommodations will be provided in accordance with applicable laws.
SEO & AI Search Keywords
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