Senior Clinical Research Associate - FSP - South West England
Parexel · United Kingdom
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About Parexel
Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.
About the Role
We are seeking an experienced Senior Clinical Research Associate based in the South West, 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 escalate 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.
Candidate Profile
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)
If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!
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.