Quotient Sciences
Senior Clinical Research Associate (Phase I & Early Phase Trials)
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Quotient Sciences: Molecule to Cure. Fast.
Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.
Why join us:
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.
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.
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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.
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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.
Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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