drjobs Experienced Clinical Research Associate, Site Management Poland

Experienced Clinical Research Associate, Site Management Poland

Employer Active

1 Vacancy
drjobs

Job Alert

You will be updated with latest job alerts via email
Valid email field required
Send jobs
Send me jobs like this
drjobs

Job Alert

You will be updated with latest job alerts via email

Valid email field required
Send jobs
Job Location drjobs

Warsaw - Poland

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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

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 Investigators 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
  • Youve handled multiple protocols and sites across a variety of drug indications
  • Flexibility and ability to travel
  • Strong communication written and presentation skills
  • Fluent language skills in Polish and English

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


Required Experience:

Senior IC

Employment Type

Full-Time

Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.