Senior Clinical Research Associate (Phase I & Early Phase Trials)

Overview

As a Senior Clinical Research Associate, you will help build and shape Quotient Sciences’ clinical monitoring function across early-phase trials. You will partner with Clinical Operations, Quality Assurance and study teams to uphold quality, compliance and participant safety. The role blends hands-on monitoring with strategic influence to establish standards and drive inspection readiness. You will mentor junior CRA talent and contribute to a best-in-class monitoring service. You will work across Phase I healthy volunteers and early-phase patient studies, shaping how monitoring is delivered in a growing organization.

Responsibilities

• Lead monitoring activities across Phase I HV and early-phase patient studies
• Conduct site qualification, initiation, routine monitoring and close-out visits
• Ensure participant safety, protocol compliance and data integrity
• Prepare, review and submit monitoring documentation and reports within timelines
• Identify and address protocol deviations, GCP findings and corrective actions
• Support investigators and study teams to resolve compliance issues
• Oversee essential study documentation and inspection readiness
• Perform drug accountability oversight and support risk-based monitoring
• Act as monitoring lead across studies and main contact for internal teams, sites and CROs
• Help establish and improve monitoring processes, standards and practices
• Define and track monitoring KPIs and quality metrics for study leadership
• Contribute to recruitment, onboarding and mentoring of CRA team members
• Support GCP training, inspection readiness activities, audits and regulatory inspections
• Collaborate with QA and Clinical Operations to drive continuous improvement

Key requirements

• Degree in Life Sciences, Nursing, Healthcare or related discipline, or equivalent experience
• Minimum 5 years’ CRA experience in pharma, biotech or CRO
• Independent on-site monitoring experience
• Strong knowledge of ICH-GCP and UK/EU/international regulatory requirements
• Experience supporting Phase I and/or early-phase patient trials
• Experience managing monitoring documentation and site activities across lifecycles
• Excellent organizational skills and ability to manage multiple priorities
• Strong communication and stakeholder management with constructive challenge
• Ability to work independently, make decisions and solve complex problems

• stakeholder management
• effective communication
• problem solving
• ICH-GCP
• risk-based monitoring
• site qualification and initiation

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