Senior Clinical Research Associate - FSP

ATLAS MEDICAL SERVICES LTD. STI.; United Kingdom; A distancia; GBP 65.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Vacation/holiday/sick time

Flexible benefit portal

Car allowance

Descripción de la vacante

Parexel is seeking a Senior Clinical Research Associate (FSP) in the United Kingdom, ideally in the South West, with willingness to travel regularly.

You will lead monitoring activities, ensure patient safety and regulatory compliance, and collaborate with local study teams to deliver high-quality trial data across CTMS/eTMF environments. Remote work options supported.

Formación

• Bachelor’s degree in life sciences or equivalent.
• Significant clinical research experience in site monitoring and trial execution.
• Excellent knowledge of ICH GCP and local regulatory requirements.
• Experience with CTMS, eTMF, and other trial systems.
• Strong written and verbal communication, organizational, and problem solving skills.
• Proficiency in written and spoken English; ability to travel nationally and internationally.
• Valid driving licence where applicable.

Responsabilidades

• Lead initiation, routine monitoring, and close-out of sites per protocol and ICH GCP; ensure sponsor procedures and local regulations are followed.
• Serve as primary contact for investigative sites to support study execution and recruitment goals.
• Train and advise investigators on study requirements, protocol execution, and risk-based quality management.
• Conduct onsite and remote monitoring, SDV, and CRF review per monitoring plans.
• Identify, manage, and escalate site and study issues to ensure timely progress.
• Perform site quality risk assessments and adapt monitoring activities as needed.

Conocimientos

Site management

Clinical monitoring

Stakeholder engagement

Regulatory compliance

CTMS familiarity

Communication

English proficiency

Travel readiness

Educación

Bachelor’s degree in life sciences

Herramientas

CTMS

eTMF

Descripción del empleo

Senior Clinical Research Associate - FSP

Primary Location: United Kingdom, Remote

Job ID: R0000047565

Category: Clinical Trials

We are seeking an experienced Senior Clinical Research Associate based in the UK, ideally in the South West of England (or at least willing to travel there regularly), to join one of our key sponsors. This role is responsible for the successful delivery of clinical studies at assigned investigator sites, serving as the primary point of contact for site management, monitoring, and study execution activities.

As an active member of the local study team, you will work closely with clinical operations colleagues and stakeholders to ensure high quality study delivery, patient safety, regulatory compliance, and operational excellence.

This is an opportunity to contribute directly to the advancement of innovative therapies while building your expertise within a world class research environment.

Key Responsibilities

• Lead the preparation, initiation, routine monitoring, and close out of assigned clinical trial sites in accordance with protocol requirements, ICH GCP guidelines, sponsor procedures, and local regulations.
• Serve as the primary contact for investigative sites, building strong partnerships that support successful study execution and patient recruitment goals.
• Train, support, and advise investigators and site personnel on study requirements, protocol execution, and Risk Based Quality Management principles.
• Conduct onsite and remote monitoring visits, source data review, source data verification, and case report form review in accordance with study monitoring plans.
• Proactively identify, manage, and escalation site and study related issues to ensure timely resolution and continued study progress.
• Perform site quality risk assessments and adapt monitoring activities as appropriate throughout the study lifecycle.
• Ensure timely and accurate reporting of serious adverse events, query resolution, and quality study data collection.
• Maintain accurate and up to date study information within CTMS and other required clinical systems.
• Support the collection, review, upload, and maintenance of essential documents within the eTMF and investigator site files, ensuring inspection readiness.
• Collaborate with local study teams, quality colleagues, and other stakeholders to support audits, inspections, and successful study delivery.
• Manage study supplies, study drug accountability activities, and associated documentation as required.
• Contribute insights regarding site performance, investigator engagement, and local research landscapes to support study success.

You’ll Thrive In This Role If You Bring

• Strong capabilities in site management, clinical monitoring, and stakeholder engagement.
• Experience working within clinical research and regulated environments.
• The ability to collaborate effectively across cross functional teams and communicate confidently with investigators and site personnel.
• A patient focused mindset and commitment to quality, compliance, and operational excellence.
• Comfort working with CTMS, eTMF, remote monitoring tools, and other clinical trial systems.
• Strong organizational skills with the ability to manage multiple priorities and timelines
• A proactive approach to problem solving and continuous improvement.

Required Qualifications

• Bachelor’s degree in a life science or related discipline, or equivalent experience aligned with local market requirements.
• Significant clinical research experience with demonstrated expertise in site monitoring and clinical trial execution.
• Excellent knowledge of ICH GCP and working knowledge of applicable local regulatory requirements.
• Good understanding of clinical study management, study drug handling, data management, and clinical trial processes.
• Experience using CTMS, eTMF, and other clinical research technologies and systems.
• Strong written and verbal communication, organizational, and problem solving skills.
• Proficiency in written and spoken English.
• Ability to travel nationally and internationally as required.
• Valid driving licence in accordance with local country requirements, where applicable.

Preferred Qualifications

• Experience supporting global clinical studies within a pharmaceutical or biotechnology environment.
• Familiarity with risk based monitoring approaches, including remote monitoring methodologies.
• Experience performing as a CRA/Senior CRA within Oncology clinical trials.
• Experience supporting regulatory inspections and audit readiness activities.
• Strong cultural awareness and experience collaborating with global teams.
• Demonstrated ability to identify efficiencies and contribute to high quality clinical trial delivery.

Benefits And Compensation

• Health, Vision & Dental Insurance
• Vacation/Holiday/Sick Time
• Flexible benefit portal
• Car or car allowance (only applicable roles)

Benefits

Benefits vary by country, but Parexel is passionate about our team’s overall wellness.

Career Advancement

We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career.

Culture

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.