Experienced Clinical Research Associate, Sponsor Dedicated

Nanosep AB; Reading; On-site; GBP 30,000 - 60,000; Full time

Job summary

Join a forward-thinking company dedicated to advancing healthcare through innovative clinical research. As a Clinical Research Associate, you will play a pivotal role in monitoring sites, ensuring compliance with regulatory standards, and managing study progress. With opportunities for genuine career development and access to cutting-edge tools, this position is ideal for those eager to make a meaningful impact in the life sciences sector. Embrace the chance to work with diverse teams and contribute to projects that improve patient outcomes worldwide. If you're passionate about driving healthcare forward, this role is for you.

Benefits

Career Development Opportunities

Investment in Team Stability

Access to Innovative Tools

Flexible Working Environment

Qualifications

• Life science degree or equivalent qualification required.
• Experience in independent on-site monitoring and managing multiple protocols.

Responsibilities

• Perform site monitoring visits in accordance with regulatory requirements.
• Evaluate the quality and integrity of site practices and manage study progress.

Skills

Site Monitoring

Communication Skills

Flexibility

Presentation Skills

Education

Life Science Degree

Tools

iPad

Site Visit Apps

Report Apps

Job description

Our Sponsor Dedicated (cFSP) team is growing, and we are looking for aspiring CRAs of all levels to join us on our mission to drive healthcare forward!

What We Offer

• The chance to work on cutting-edge medicines at the forefront of new medicines development.
• Access to significant data pools through IQVIA, enabling better site selection and recruitment, which makes the CRA role more efficient and discussions at sites more productive. Next-generation clinical development!
• Genuine career development opportunities for those who want to grow within the organization.
• Investment in team stability to ensure a consistent workload.
• Provision of an iPad and access to innovative tools such as site visit apps and report apps to enhance efficiency.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, and close-out) in accordance with the scope of work and regulatory requirements, including GCP and ICH guidelines.
• Work with sites to develop, drive, and track subject recruitment plans aligned with project needs to improve predictability.
• Administer protocol and related study training to sites and establish regular communication to manage expectations and issues.
• Evaluate the quality and integrity of site practices, ensuring proper conduct of the protocol and adherence to regulations, escalating issues as needed.
• Manage study progress by tracking regulatory submissions, approvals, recruitment, CRF completion, data queries, and resolutions. Support start-up phase if applicable.
• Ensure site documents are properly filed in the Trial Master File (TMF) and maintain the Investigator's Site File (ISF) according to GCP and regulatory standards.
• Create and maintain documentation on site management, monitoring findings, and action plans, including visit reports and follow-up correspondence.
• Collaborate with study team members to support project execution.
• If applicable, support the development of site-specific recruitment plans and manage site finances according to trial agreements.

Requirements

• Life science degree or equivalent qualification.
• Experience in independent on-site monitoring.
• Experience managing multiple protocols and sites across various drug indications.
• Flexibility and willingness to travel.
• Strong communication, written, and presentation skills.

Awards

• Fortune Magazine's World's Most Admired Companies list for four consecutive years, ranked #1 in its category.
• Best AI-based Solution for Healthcare Award in 2023 AI Breakthrough Awards.

This role is not eligible for UK visa sponsorship.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments, aiming to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.

We value diverse talent with curious minds and a commitment to innovation. Everyone at IQVIA contributes to our shared goal of improving lives through healthcare. Thank you for your interest in growing your career with us.

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