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DOCS CRA II *** Portugal *** Officebased Lisbon in Portugal, United States

CRA II * Portugal * Officebased Lisbon

Ref #: 26822

Employment type: Permanent - Full-Time

Location: Portugal, Lisbon

Posted: 11-Feb-2021


• Conduct of clinical research activities independently in accordance to ICH GCP and SOP’s;

  • Investigator identification and selection;

  • Investigator Meeting activities;

  • Design and review of study material, such as patient information sheets, consent forms, monitoring plans etc;

  • Timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements;

  • Site visits, including Pre study, initiation, monitoring and close out visits;

  • Maintain all files and documentation pertaining to the studies;

  • Complete accurate study status reports;

  • Ensure the correct storage & accountability of study materials and investigational product;

  • Process case record forms to the required quality standards and timeliness;

  • Deal with clinical generated queries in a timely manner;

  • Ensure correct archiving of files on completion of a study;

  • Maintain patient and sponsor confidentiality;

  • Co-ordinate and/or participate in feasibility studies for new proposals, as required.

• Effective Communication:

  • Maintain professionalism at all times

  • Keep the project manager or designees regularly informed

  • Motivate investigators in order to achieve recruitment targets

  • Present at meetings as required.

• What is Required:

  • Education: BSN/BS/MS or BA required

  • Experience: a minimum of 1-2 years independent monitoring experience

  • Knowledge of Microsoft Office applications especially Excel

  • English: Fluent spoken & written

  • Good interpersonal skills demonstrated as proactive, enthusiastic, and independent thinker

  • Ability to collaborate and build strong relationships with all functions involved in the trial

  • Works and meets deadlines with some supervision

  • Must be able to travel in accordance with company and project requirements

• What is Offered:

We offer a permanent contract, full time role based in Lisbon


DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.