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    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
  • View similar jobs with this employer
    • An understanding of the wider strategic environment UKRI operates in and an interest or understanding of the research environment and related Government…
    • Understanding of medical device cybersecurity standards.
    • Ensure all service activities comply with UK medical device regulations and company procedures.
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    • Review medical reports and lab results.
    • Review medical records of potential study participants.
    • Provision of medical care and oversight of clinical trial…
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    • Building and maintaining strong relationships with key contacts across UKRI’s other relevant priority programmes and external stakeholders from government…
    • IQVIA has access to significant data pools allowing better site selection and recruitment.
    • Perform site monitoring visits (selection, initiation, monitoring and…
  • View similar jobs with this employer
    • Review medical reports and lab results.
    • Review medical records of potential study participants.
    • Provision of medical care and oversight of clinical trial…
  • View similar jobs with this employer
    • Review medical reports and lab results.
    • Review medical records of potential study participants.
    • Provision of medical care and oversight of clinical trial…
    • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference…
    • Working on a 4 on 4 off continental shift pattern (involving working days and nights) and liaising closely with the Production department, you will provide an…
    • Keep up to date with relevant medical research, technology and evidence-based medical practice by attending continuing education courses and professional…
    • Location: Remote with visits to Norwich site, initially for 2 days per week.
    • Built on a strong heritage and great client relationships, we harness deep industry…

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Job Post Details

Clinical Research Associate - job post

IQVIA
3.7 out of 5 stars
Chesterfield
Full-time
You must create an Indeed account before continuing to the company website to apply

Job details

Job type

  • Full-time

Location

Chesterfield

Full 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

Apply today and forge a career with greater purpose, make an impact and never stop learning!

Responsibilities

  • 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.

Requirements

  • 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 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

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.

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