Clinical Research Associate II

IQVIA; Bath; On-site; GBP 50,000 - 65,000; Full time

Job summary

IQVIA is seeking a Senior CRA to join the Clinical Functional Service Partnership (CFSP) team in the UK. The role involves on-site monitoring across sponsor programs, ensuring patient safety and data integrity, and collaborating with cross-functional study teams.

You will bring 2+ years of on-site monitoring experience, strong knowledge of GCP/ICH guidelines, and excellent communication to mentor junior staff and drive study timelines in a dynamic environment.

Qualifications

• University degree in Life Sciences or Health Sciences or related field.
• Minimum 2 years on-site monitoring experience in CRO/pharma/biotech.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Experience in a sponsor-dedicated or CFSP environment preferred.
• Excellent communication and stakeholder management skills.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits per protocol and regulatory guidelines.
• Ensure sites maintain patient safety, data integrity, protocol compliance, and study quality.
• Build relationships with investigators and site personnel; provide coaching and support.
• Monitor progress, regulatory documentation, recruitment, data queries, and site performance metrics.
• Collaborate with cross-functional teams to support study delivery and timelines.
• Mentor junior team members through coaching and co-monitoring activities.
• Support study start-up, maintenance, close-out, and site financial activities as needed.

Skills

Life Sciences degree

GCP knowledge

ICH regulations

Excellent communication

Education

Bachelor's degree in Life Sciences

Job description

Why Join Clinical Functional Service Partnerships (CFSP)?

At IQVIA, our Clinical Functional Service Partnership (CFSP) model gives you the best of both worlds: the variety and sponsor-level exposure of working as an embedded member of a leading pharmaceutical or biotechnology team, backed by the stability, global infrastructure, and career support of IQVIA. You'll develop deep, specialist expertise on a dedicated program, with the flexibility to expand across sponsors and therapeutic areas as your career progresses - and the security of a long-term IQVIA career even as individual programs evolve.

Through our long-standing partnerships with the world's leading pharmaceutical and biotechnology companies, you'll contribute to clinical research programs that bring innovative treatments to patients worldwide, working across all phases of development and a broad range of therapeutic areas, within a culture that supports flexibility, continuous learning, and wellbeing.

Key Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
• Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
• Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
• Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications.
• Identify, assess, and appropriately escalat study risks, site issues, and quality concerns while driving timely resolution.
• Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.
• Mentor and support junior clinical team members through coaching, training, and co-monitoring activities, as applicable.
• Contribute to continuous improvement initiatives and support study start-up, maintenance, close-out, and site financial activities as required.

What You’ll Bring

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
• 2 years minimum on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare environment.
• Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Preferrable experience in a sponsor-dedicated or cFSP environment.
• Knowledge of patient recruitment and study start-up activities is preferred.
• Excellent communication, organizational, and stakeholder management skills.
• Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams.
• Willingness to travel within the assigned region (up to 40-60% of working time).

Please note this position cannot offer visa sponsorship, candidates must hold right to work in UK & Ireland.

Build Your Future with IQVIA

As a Senior CRA at IQVIA, you'll apply your clinical research expertise to drive meaningful outcomes for patients and sponsors around the world. You'll work on innovative studies across a variety of therapeutic areas, collaborate with industry-leading professionals, and take on increasingly strategic responsibilities throughout the clinical trial lifecycle. With continuous professional development, global career opportunities, and a culture that values expertise and innovation, IQVIA provides the platform to elevate your career and make a lasting impact on healthcare.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.