Experienced Clinical Research Associate - Hungary SM

Our multi-sponsor, Site Management team is growing, join us on our mission to drive healthcare forward!

Job Overview:
A CRA in our Site Management team will perform monitoring and site management work to ensure that sites are conducting the studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements.
• 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 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:

• Life science degree.
• Experience with multiple protocols and sites across a variety of drug indications
• Independent on-site monitoring experience.
• Flexibility and ability to travel.
• Strong communication, written and presentation skills.
• Proficiency in Hungarian and English language.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

What We Offer:

• 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.
• Genuine career development opportunities in an international, highly professional and friendly working atmosphere.

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