Clinical Research Associate 2 FSO Model Portugal

Oeiras - Portugal

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Job Overview:

Site monitoring and site management responsibility for clinical studies according to Company and/or Sponsor Standard Operating Procedures and Regulatory Guidelines. Assures the implementation of project plans as assigned.

Summary of Responsibilities:

Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites maintenance of study files conduct of pre-study and initiation visits; liaise with vendors; and other duties as assigned.
General On-Site Monitoring Responsibilities.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Ensure audit readiness at the site level.
Track and follow-up on Serious Adverse Event (SAE) reporting process production of reports narratives and follow up of SAEs.

Qualifications (Minimum Required):

University or college degree or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure). An equivalent amount of experience can be substituted as appropriate.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Basic knowledge of Regulatory Guidelines.
Basic understanding of the clinical trial process.
Fluent in local office language and in English both written and verbal.

Experience (Minimum Required):

1 year of experience as a CRA operating with Portuguese centers and regulation.
Basic understanding of Regulatory Guidelines.
Valid Drivers License.

Preferred Qualifications Include:

One (1) or more years additional experience in a related field (i.e. medical clinical pharmaceutical laboratory research data analysis data management or technical writing) is preferred
Experience using a clinical trial management system (CTMS).

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Required Experience:

Job Overview:Site monitoring and site management responsibility for clinical studies according to Company and/or Sponsor Standard Operating Procedures and Regulatory Guidelines. Assures the implementation of project plans as assigned.Summary of Responsibilities:Responsible for all aspects of study s...