The posting
The Role At Quotient Sciences, we're redefining the way medicines are developed by bringing together drug development and clinical testing under one integrated model. As we continue to grow our clinical capabilities, we have an exciting opportunity for an experienced Senior Clinical Research Associate to help build and shape our clinical monitoring function. This is a unique role for a senior clinical research professional who wants to do more than deliver monitoring activities. You'll play a key part in establishing monitoring standards, driving inspection readiness, influencing future operating models and supporting the growth of our clinical monitoring capability across both healthy volunteer and patient studies. Working closely with Clinical Operations, Quality Assurance and study teams, you'll ensure that studies are conducted to the highest standards of quality, compliance and participant safety. You'll also have the opportunity to mentor future CRA talent and contribute to the development of a best-in-class monitoring service. If you're looking for a role where you can combine hands-on monitoring expertise with strategic influence and leadership, we'd love to hear from you. Key Responsibilities
Lead clinical monitoring activities across Phase I healthy volunteer studies and early phase patient trials. Conduct site qualification, site initiation, routine monitoring and close-out visits. Ensure participant safety, protocol compliance and data integrity throughout the clinical trial lifecycle. Prepare, review and submit monitoring documentation, visit reports and follow-up letters within agreed timelines. Identify, document and follow up on protocol deviations, GCP findings and corrective actions. Support investigators and study teams to resolve monitoring findings and compliance issues. Oversee the collection and maintenance of essential study documentation to ensure inspection readiness. Perform drug accountability oversight activities and support risk-based monitoring approaches. Act as a monitoring lead across studies and serve as a key contact for internal teams, external sites and CRO partners. Help establish and continuously improve monitoring processes, quality standards and working practices. Define and track monitoring KPIs and quality metrics, providing updates to study and leadership forums. Contribute to the recruitment, onboarding and mentoring of future CRA team members. Support GCP training, inspection readiness activities, audits and regulatory inspections. Work collaboratively with Quality Assurance and Clinical Operations to drive continuous improvement across clinical trials.
Skills and Experience Required Essential
Degree in Life Sciences, Nursing, Healthcare or a related discipline, or equivalent experience. Minimum of 5 years' Clinical Research Associate experience within a pharmaceutical, biotechnology or CRO environment. Proven independent on-site monitoring experience. Strong knowledge of ICH-GCP and applicable UK, EU and international regulatory requirements. Experience supporting Phase I and/or early phase patient clinical trials. Experience managing monitoring documentation and site activities across the study lifecycle. Excellent organisational skills with the ability to manage multiple priorities effectively. Strong communication and stakeholder management skills, with the confidence to challenge constructively when required. Ability to work independently, make sound decisions and solve complex problems.
Desirable
Experience supporting regulatory inspections and audits. Experience mentoring, coaching or developing junior CRA colleagues. Experience helping establish or enhance clinical monitoring processes or functions. Experience working with IWRS/IRT and ePRO systems. Experience working within sponsor and CRO partnership models. Experience developing monitoring KPIs, quality measures or performance metrics.
Learning Opportunities
Play a leading role in building and shaping Quotient Sciences' clinical monitoring capability. Influence monitoring strategy, quality standards and future operating models. Develop leadership and mentoring experience within a growing function. Work across a diverse portfolio of Phase I and early phase clinical studies. Collaborate with experts across Clinical Operations, Quality Assurance and Regulatory disciplines. Gain exposure to innovative drug development programmes and integrated clinical research delivery. Contribute to inspection readiness initiatives and continuous improvement projects that have a lasting impact across the organisation.
This role offers a rare opportunity to combine hands-on clinical monitoring expertise with the chance to influence how monitoring is delivered within a growing and evolving organisation. If you're passionate about quality, compliance and clinical research excellence, we'd love to hear from you.
