Senior Clinical Research Associate II

2 semanas atrás


Lisboa, Lisboa, Portugal LIS Fortrea Development Ltd Sucursal em Portugal Tempo inteiro

Overview

">LIS Fortrea Development Ltd Sucursal em Portugal is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience.

Salary

">We offer an estimated annual salary of €65,000 to €80,000, depending on location and experience.

Job Description

">The Senior Clinical Research Associate II is responsible and accountable for site monitoring and site management for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. This role assures the implementation of project plans as assigned, functions as leader for projects of limited scope, as assigned and assumes line management responsibilities, as assigned.

Responsibilities:

">- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.- Responsible for all aspects of site management as prescribed in the project plans.- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.- 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.- Monitor data for missing or implausible data.

Required Skills and Qualifications:

">- 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.- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.- Thorough knowledge of regulatory requirements.- Thorough understanding of the drug development process.- Fluent in local office language and in English, both written and verbal.- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Benefits:

">We offer a competitive benefits package, including health insurance, retirement plan, and paid time off.

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