CRA2 - Multi-Sponsor Department

IQVIA LLC; Eccles; On-site; GBP 30,000 - 42,000; Full time

Job summary

IQVIA UK's Site Management team is seeking junior and experienced Clinical Research Associates to perform on-site monitoring visits across diverse sites, ensuring GCP/ICH compliance and protocol adherence.

The role involves coordinating subject recruitment plans, training sites on the protocol, maintaining regular communication, and managing regulatory submissions, ISF/TMF, and data queries while supporting start-up activities when needed.

Qualifications

• Experience of independent on-site monitoring.
• Managed multiple clinical trial protocols across diverse sites.
• Strong knowledge of GCP and ICH guidelines.
• Bachelor's degree in life sciences or equivalent.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH.
• Collaborate with sites to drive subject recruitment plans.
• Train sites on the protocol and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory compliance.
• Escalate quality issues as appropriate.
• Track regulatory submissions, recruitment, CRF completion, data queries.
• Support start-up phase if needed.
• Maintain Trial Master File and ISF per regulatory requirements.
• Generate visit reports and action letters.
• Collaborate with study team for project execution.

Skills

On-site monitoring

Site management

GCP/ICH knowledge

Travel flexibility

Education

Life science degree

Job description

IQVIA UK's Site Management (multi-sponsor) team is growing and seeking junior and experienced Clinical Research Associates.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• 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 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

Requirements

• Experience of independent on-site monitoring
• You have successfully managed multiple clinical trial protocols across diverse investigative sites
• 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
• Please note - 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 intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

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.