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).
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