CRA II/ Sr CRA
Syneos Health
Poland- POL--
26 min. temu

Summary :

Here at Syneos Health we are currently recruiting for a Clinical Research Associate II or Sr level to be based in office in Warsaw and work closely with one of Global Pharmaceutical company.

Job Details :

  • Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives.
  • This includes but is not limited to :

    oOverview the overall activities of site personnel over whom there is no direct authority and motivate / influence them to meet study objectives.

    oEnsure quality of data submitted from study sites and assures timely submission of data.Train study site personnel on the protocol and applicable regulatory requirements.

  • Facilitate Quality Assurance Audit processes as indicated.
  • Report monitoring activities and study site conduct accurately and completely.
  • Prepares CA and / or EC documentation, ensures submissions and / or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and / or EC questions and related follow-up.
  • Negotiates investigator / hospital agreements with stakeholders.
  • Uses multiple technologies to maintain open and frequent communication with internal & external customers.
  • Requirements

    The ideal candidate will need the following experience / skills to be considered :

  • Minimum of 1 year of clinical monitoring.
  • Start-up experience will be asset.
  • Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  • Current in-depth knowledge of regulations governing clinical research, ICH / GCP Guidelines and applicable regulations.
  • Good written and verbal communication skills. Written and verbal fluency in English and local language.
  • Previous experience with electronic data capture systems is desirable.
  • We have a comprehensive benefits package and offer highly competitive remuneration.

    If you have the required experience for this position and are eligible to work in the required location then please apply by CV.

    Please be advised that due to volume of received applications, only selected candidates will be contacted back.

    To find out more about our company and search and apply for other open jobs please visit our website

    LI-MB1

    Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

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