Senior Clinical Research Associate

Chiltern Ver Empresa

Não especificado
Licenciatura

Chiltern is Europe’s largest privately owned Clinical Research Organization, with over 4000 employees and 47 offices throughout Europe, both Eastern and Western, North America and in Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.

The Chiltern Source department is currently looking for a SRCRA working directly with a top 20 Pharma, Office based in Lisbon.

DUTIES:

  • To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits in accordance with study monitoring plan and client’s SOPs.
  • Develop and maintain good working relationships with assigned study sites in order to effectively manage each site through the clinical trial and be proactive in dealing with any issues, e.g. recruitment
  • Document all site visits within visit reports in a timely manner.
  • Appropriate follow-up with sites after monitoring visits to document findings and resolution of identified issues.
  • Be an integral team member and support the study team to ensure the smooth-running of the clinical trial.
  • Update all Client Clinical Trial Systems as required to provide effective study status updates for assigned sites
  • Requirements:
  • Around 4 years working experience in a similar position at pharmaceutical company or CRO
  • Health care or Health Sciences graduate
  • Experience in performing all visits types: SQV, SIV, SMV, and COV
  • Experience across a number of phases and therapeutic areas
  • Knowledge and experience of Regulatory and Ethics Committees submissions.
  • Competence using electronic systems e.g. CTMS, eCRF
  • Basic IT competence required (email, internet, word, excel)
  • Good standard of oral and written English
  • Proactive and with field experience

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