Clinical Research Associate

Iqvia's Site Management; Reading; On-site; GBP 38,000 - 52,000; Full time

Job summary

IQVIA's Site Management (multi-sponsor) team is seeking a Clinical Research Associate to join our mission to help create a healthier world. The CRA will support Oncology studies and cover sites across the UK, performing site monitoring visits and ensuring compliant data and patient safety.

The role requires a life science degree, deep knowledge of GCP/ICH, and flexibility to travel to UK sites. You will collaborate with investigators, manage regulatory documentation, and help drive recruitment

Qualifications

• GCP knowledge and experience conducting clinical site monitoring.
• Familiarity with ICH guidelines and regulatory requirements.
• Willingness to travel to multiple UK sites as required.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Drive/adapt subject recruitment plans with sites to improve predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
• Ensure TMF/ISF documentation is accurate and up-to-date.
• Create and maintain site management documentation and visit reports.
• Collaborate with study team members for project execution.

Skills

GCP knowledge

ICH guidelines knowledge

Willingness to travel

Education

Life science degree

Job description

IQVIA's Site Management (multi-sponsor) team are seeking a Clinical Research Associate to join us on our mission to help create a healthier world. The Clinical Research Associate will support Oncology studies and cover sites across the UK.

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

• Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.
• In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Life science degree educated or equivalent industry experience.
• Flexibility to travel to sites as required.

Please note - this role is not eligible for visa sponsorshipIQVIA 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 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

Location: Reading, Berkshire, United Kingdom; Oxfordshire, England, United Kingdom; Chesterfield, Derbyshire, United Kingdom; Brighton, Brighton and Hove, United Kingdom; Nottingham, United Kingdom; Manchester, United Kingdom. Type: Full time.