At a Glance
- Tasks: Lead site monitoring and ensure high-quality clinical trial data while protecting patient safety.
- Company: Join Worldwide Clinical Trials, a global leader in clinical research with a purpose.
- Benefits: Home-based role with opportunities for travel, mentorship, and professional growth.
- Other info: Collaborative environment that values diverse perspectives and encourages career development.
- Why this job: Make a real impact on patients' lives through innovative clinical research.
- Qualifications: Experience as a CRA with strong leadership and communication skills required.
The predicted salary is between 40500 - 49500 £ per year.
Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.
Make an Impact as a Senior CRA at Worldwide. Take ownership of site monitoring activities that protect patient safety, strengthen protocol compliance, and ensure high-quality clinical trial data. As a Senior Clinical Research Associate, you’ll manage sites across the study lifecycle, from qualification and initiation through ongoing monitoring and close-out.
You’ll also bring your experience beyond individual site management, with opportunities to coordinate CRAs as a Lead CRA, review monitoring reports, mentor less experienced colleagues, develop study-specific tools and training, and contribute to study planning and investigator meetings. Your clinical research expertise will help study teams identify and resolve site challenges, maintain strong relationships with investigators and site staff, and deliver studies in line with GCP, regulatory requirements, protocols, and SOPs.
This is a home-based Clinical Research Associate role supporting sites across the United Kingdom. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 8-10 days per month.
What You'll Do
- Lead site qualification, initiation, interim monitoring, management, and close-out activities in accordance with protocols, GCP, applicable regulations, and SOPs.
- Protect patient safety and data quality by reviewing informed consent, safety information, source documentation, CRFs, and protocol compliance.
- Partner with investigators and site teams to resolve data queries, maintain regulatory and ethical documentation, support the Investigator Site File, and provide required documentation for the Trial Master File.
- Coordinate CRAs as a Lead CRA on global studies, working with Project Management to evaluate study milestones and deliverables.
- Mentor less experienced CRAs and site staff, including conducting accompanied visits, providing monitoring report feedback, and delivering study-specific training.
- Support study execution by developing monitoring plans, tools, and templates and coordinating the shipment and receipt of study materials.
- Ensure appropriate investigational product receipt, accountability, return, or destruction at assigned sites.
- Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, and the development of protocols and CRFs.
What You'll Bring
- Education and CRA experience: an MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least 3 years of CRA experience; a four-year degree in medical, biological, physical, health, pharmacy, or another related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably nursing or life sciences, with at least 7 years of CRA experience.
- Extensive knowledge of clinical research principles and processes, GCP, SOPs, FDA and/or EU regulations and directives, ICH Guidelines, and applicable local regulatory requirements.
- Strong therapeutic-area expertise across two to three therapeutic areas, sufficient to operate as a Lead CRA where appropriate.
- Demonstrated leadership and communication skills, with the ability to mentor colleagues, guide site teams, solve problems, manage priorities, and contribute to monitoring and site-management process improvements.
- Proficiency with Microsoft Office, IxRS, and EDC systems.
- Experience in full-service monitoring PREFERRED.
- A valid current passport and driving licence.
- Proficiency in spoken and written English.
Discover the Difference We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials.
Senior Clinical Research Associate - CNS/Oncology UK in London employer: Worldwide Clinical Trials
Worldwide Clinical Trials is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals passionate about clinical research. With a strong emphasis on employee growth, the company offers numerous opportunities for skill development and career advancement, all while working in a diverse environment that values creativity and teamwork. Located in a vibrant area, employees benefit from a supportive atmosphere that encourages meaningful contributions to patient engagement activities.