Experienced Clinical Research Associate

IQVIA; West Midlands Combined Authority; On-site; GBP 35,000 - 50,000; Full time

Job summary

A global healthcare insights provider in England is seeking an experienced Clinical Research Associate (CRA) to perform site monitoring visits and ensure compliance with regulatory standards. The ideal candidate should have a life science degree and prior experience in independent site monitoring. This position offers opportunities for career development and involves regular travel. Please note this role is not eligible for UK Visa Sponsorship.

Benefits

Career development opportunities

iPad for work efficiency

Stable workload management

Qualifications

• Life science degree required.
• Experience in independent on-site monitoring.
• Ability to handle multiple protocols across various drug indications.

Responsibilities

• Perform site monitoring visits per contracted scope of work.
• Work with sites to adapt recruitment plans.
• Ensure regulatory compliance and quality of studies.
• Manage progress of assigned studies and documentation.

Skills

Independent on-site monitoring

Strong communication skills

Flexibility and ability to travel

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