Senior Clinical Research Associate (SCRA) in Nottingham

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.

About the role:

We’re looking for an experienced Senior Clinical Research Associate (SCRA) to help build and lead our in‑house clinical monitoring capability. This role goes beyond traditional CRA responsibilities. You’ll help shape our monitoring approach across early-phase (Phase I) healthy volunteer studies and expanding patient trials (Phase 1b/2a) at Quotient sites in Nottingham and Miami, as well as partner trial locations.

What you’ll be doing:

• Establish, embed, and continuously improve clinical monitoring services for Phase I (healthy volunteer) or patient trials conducted at both Quotient sites and external trial sites, overseen by Quotient.
• Develop risk‑based, scalable and inspection‑ready monitoring frameworks.
• Create and embed templates, tools, SOPs, training and guidance including monitoring plans, monitoring visit reports (including SIV and COV), site initiation visit materials, issue escalation and deviation management pathways.
• Act as subject matter expert for clinical monitoring across the organisation.
• Assume Lead CRA responsibilities across assigned studies: site initiation, routine monitoring, and close‑out visits.
• Risk‑based and remote monitoring where appropriate.
• Preparation, review and timely submission of all monitoring documentation, including visit reports and follow‑up letters, in accordance with defined KPIs.
• Ensure trials are conducted in compliance with the study protocol, ICH‑GCP, regulatory requirements, and internal quality standards.
• Provide monitoring oversight of external patient sites and partners, ensuring consistency and quality.
• Identify, document, and follow up on deviations, findings, and corrective actions.
• Support inspection readiness and participate in audits and regulatory inspections.
• Work closely with cross functional teams including Clinical Operations, Quality Assurance, Project Management, Medical and Regulatory colleagues.
• Support the development of CRAs as the team grows.

What we’re looking for:

• Degree in Life Sciences, Nursing, Pharmacy (or equivalent experience).
• 5+ years experience working as a CRA with independent monitoring responsibility.
• Strong knowledge of ICH‑GCP and early‑phase clinical trial conduct.
• Experience monitoring Phase I and/or early patient trials.
• Experience working with external sites, partners, or CROs.
• Ability to work autonomously and make sound, risk‑based decisions.
• Excellent communication and stakeholder‑management skills.
• Proven ability to build effective working relationships with trial centre staff and colleagues.
• Flexible approach and willingness to significant travel.
• Experience monitoring patient or multi‑site trials.
• Involvement in inspections or audits.
• Experience in establishing or improving monitoring processes.
• Experience with core clinical systems and familiarity with ePRO and IWRS/IRT platforms.
• Experience mentoring, coaching or informally leading peers, with the interest to take on line management responsibility as the team grows.

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.