Clinical Research Associate 2

Há 2 dias

Oeiras, Lisboa, Portugal Fortrea Tempo inteiro

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 Driver's License.

Preferred Qualifications Include:

  • One (1) or more year's 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).

Learn more about our EEO & Accommodations request here.

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