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Are you interested in the dynamic Clinical Research Industry?

Do you want to work for a leading multinational organization, renowned throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases?

We are currently looking to attract a Site Quality Specialist based from home in Hungary.

In this role you will provide quality control to the clinical trial process by ensuring all study documentation and source data is accurate and up to date at the 4 sites in the country – Budapest, Debrecen, Gyula and Zalaegerszek. You will oversee the maintenance of the Investigator Site Files (ISF) as well as perform quality compliance checks and report your activities in the relevant systems.

The successful candidate must be open to travel between the sites in the country, to comply with the quarterly plan, approximately 60% travel will be required.

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Key roles and responsibilities of the Site Quality Specialist are:

  • Acts as a quality specialist on several studies at a few sites to ensure the site compliance to protocol and regulations and guidelines
  • Participates in start-up, set-up and close out of studies from a quality perspective, ensuring adherence to the clients’ expectations
  • Tracks the flow of the CRF’s and query resolution
  • Ensures protocol visit windows are scheduled according to the protocol requirements and reports deviations
  • Oversees that ISF and study trackers are maintained as delegated
  • Assists with archiving procedures, if required
  • Frequently liaises with monitors and client representatives, and completes the preparation for monitoring visit duties and audits
  • Identifies quality issues (QI) and reports on it, and supports and mentors junior compliance coordinators in this process
  • Reviews informed consent forms for completion and escalates concerns
  • Ensures adherence to rules and regulations of ICH, GCP and other regulatory and ethical guidelines, as well as data protection regulations including SOP compliance
  • Reports any non-compliance of service level agreements
  • Highlights any auditor findings and proposes CAPA actions
  • Responsible for audit preparation and ensures audit readiness of site files

To be considered for this exciting opportunity you will need the following skills and experience:

  • At least 2 years of related previous experience
  • Solid understanding of the audit process, including audit preparation and oversight, sponsor, internal audits (regulatory authority and FDA will be advantage), as well as CAPA reporting and basic root cause analyses
  • Good understanding of theory and techniques in the data and compliance field
  • Good multitasking and project management skills in order to oversee numerous studies with a variety of therapeutic areas and size simultaneously
  • Solid understanding of quality compliance and ICH/GCP regulations
  • Good interpersonal, leadership, consultative skills
  • Fluent Hungarian and good working knowledge of business English
  • Solid MS Office Skills
  • Good understanding of medical terminology
  • Good time management skills
  • Solid attention to detail

Interested? Great, please apply now as we may close the advert earlier than the expiry date.

AES is an Affirmative Action and Equal Opportunity Employer.

Competitive salary and benefits; interesting and stable job in a multinational company; open and friendly organizational culture; opportunity for professional development in the field of clinical trials.

Accelerated Enrolment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrolment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of integrated solutions includes PatientAdvantage, PPD’s global clinical development services optimized with Acurian and Synexus enrolment capabilities. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.