Covance

Clinical Research Associate II

AR-Buenos Aires
Job Number
2017-16022
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

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 
  • General On-Site Monitoring Responsibilities: 

 

o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study 

o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 

o 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 

o Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy 

  • Prepare accurate and timely trip reports 
  • Manage small projects under direction of a Project Manager/Director as assigned 
  • Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned 
  • Review progress of projects and initiate appropriate actions to achieve target objectives 
  • Organize and make presentations at Investigator Meetings 
  • Report, write narratives and follow-up on serious adverse experiences 
  • Participate in the development of protocols and Case Report Forms as assigned 
  • Participate in writing clinical trial reports as assigned 
  • Interact with internal work groups to evaluate needs, resources and timelines 
  • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned 
  • Responsible for all aspects of registry management as prescribed in the project plans 
  • Undertake feasibility work when requested 
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 
  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned 
  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs 
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management 
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
  • Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 
  • Perform other duties as assigned by management

Education/Qualifications

Required: 

•University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) 

•In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered 

•Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements 

•Thorough knowledge of monitoring procedures 

•Basic understanding of the clinical trial process

 

Experience

Required: 

•Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) 

•Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines 

•Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs 

•Good planning, organization and problem solving abilities 

•Ability to work with minimal supervision 

•Good communication and interpersonal skills 

•Good analytical and negotiation skills 

•Computer competency 

•Fluent in local office language and in English, both written and verbal 

•Works efficiently and effectively in a matrix environment

•Bilingual in English and Spanish

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