Senior CRA

IQVIA Holdings Inc.; Reading; On-site; GBP 55,000 - 75,000; Full time

Job summary

IQVIA is seeking a Senior Clinical Research Associate (CRA) to conduct site qualification, initiation, monitoring and close-out visits in line with GCP, ICH guidelines and regulatory requirements. You will ensure patient safety, data integrity and protocol compliance across study sites in the UK.

You will train site personnel, track study progress, manage regulatory documents, and collaborate with cross-functional teams to drive study delivery.

Qualifications

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or related discipline, or equivalent combination of education and experience.
• 4 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.

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 ISF, TMF, monitoring reports, and follow-up communications.
• Identify, assess, and appropriately elevate 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.

Skills

GCP knowledge

ICH guidelines

Regulatory compliance

Communication

Education

University degree in Life Sciences or related discipline

Job description

• 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 elevate 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.
  University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
• 4 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).
  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., 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.