Ref #: 26822

Employment type: Permanent - Full-Time

Location: Portugal, Lisbon

Posted: 11-Feb-2021

Description

• 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
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