Clinical Research Associate II: Site Monitoring & Trials

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

Job summary

IQVIA UK is seeking junior and experienced Clinical Research Associates for its Site Management (multi-sponsor) team in the Leeds area.

You will perform on-site monitoring visits (initiation, monitoring and close-out) in line with GCP/ICH guidelines, drive subject recruitment plans, and provide protocol training to sites. You will maintain TMF/ISF documentation and collaborate with the study team to meet project expectations. Some travel to study sites is required.

Qualifications

• Experience of independent on-site monitoring.
• Managed multiple clinical trial protocols across diverse investigative sites.
• In depth knowledge of GCP and ICH guidelines.
• Life science degree or equivalent industry experience.
• Flexibility to travel to sites.

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 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

Skills

Independent on-site monitoring

Multiple protocol management

GCP/ICH knowledge

Travel flexibility

Education

Life science degree or equivalent

Job description

IQVIA UK is seeking junior and experienced Clinical Research Associates for its Site Management (multi-sponsor) team in the Leeds area.

You will perform on-site monitoring visits (initiation, monitoring and close-out) in line with GCP/ICH guidelines, drive subject recruitment plans, and provide protocol training to sites. You will maintain TMF/ISF documentation and collaborate with the study team to meet project expectations. Some travel to study sites is required.