Experienced Clinical Research Associate

QUK IQVIA Ltd.; Reading; On-site; GBP 30,000 - 45,000; Full time

Job summary

A global clinical research organization is seeking a Clinical Research Associate (CRA) in Reading, UK. The CRA will perform site monitoring visits and manage study progress, ensuring compliance with regulations. Candidates should have a life science degree and experience in independent on-site monitoring. Strong communication skills are essential. This position does not offer UK Visa Sponsorship.

Benefits

Career development opportunities

Access to cutting-edge technologies

Stable workload

iPad for work purposes

Qualifications

• Graduate in life sciences is essential.
• Experience with multiple protocols and sites is required.
• Strong communication skills are necessary.

Responsibilities

• Perform site monitoring visits according to regulations.
• Track subject recruitment plans to meet project needs.
• Administer protocol training to assigned sites.
• Evaluate study site practices and escalate quality issues.
• Manage study progress by tracking approvals and enrollments.
• Maintain documentation for site management and visit findings.

Skills

Independent on-site monitoring experience

Flexibility and ability to travel

Strong communication skills

Written and presentation skills

Education

Life science degree

Job description

Our team is growing, join us on our mission to drive healthcare forward!

What We Offer / USPs

• The chance to work on cutting edge medicines at the forefront of new medicines development
• IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development!
• We offer genuine career development opportunities for those who want to grow as part of the organization
• We invest in keeping our teams stable, so workload is consistent
• As a CRA you will receive an iPad and use of key developments such as site visit app’s, site visit report app’s that allow CRA’s to do their day job more efficiently

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
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Requirements

• You should be life science degree educated
• You have experience of independent on-site monitoring experience
• You've handled multiple protocols and sites across a variety of drug indications
• Flexibility and ability to travel
• Strong communication, written and presentation skills

** 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. Learn more at https://jobs.iqvia.com