Covance

Sr.Clinical Research Associate

BR
Job Number
2017-16371
Job Category
Clinical Research Associate
Position Type
Temporary

Job Overview

Get ready to redefine what’s possible and discover your extraordinarypotential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.  

 

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

 

Covance is seeking a Sr. Clinical Research Associate to join us in Sao Paulo, Brazil, this is a great time to join our team!

 

***We have both temporary and permanent opportunities available***

 

As a Sr. Clinical Research Associate your responsibilities will include:

 

  • Site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
  • Assures the implementation of project plans as assigned
  • 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
  • Travel, including air travel, may be required and is an essential function of the job.
  • 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 and trip report review as assigned
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Participate in the development of protocols and Case Report Forms as assigned
  • Participate in writing clinical trial reports 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
  • Language Skills Required: Speaking - English and Local Language; Writing/Reading: English and Local Language

 

 

Education/Qualifications

 

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure) and a minimum of 4 years of Clinical Monitoring experience.
  • In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience will be considered 

Experience

Minimum Required:

  • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Advanced site monitoring skills
  • Advanced study site management skills
  • Advanced registry administration skills
  • Ability to work with minimal supervision
  • Good planning and organization skills
  • Good computer skills with good working knowledge of a range of computer packages
  • Advanced verbal and written communication skills
  • Ability to train and supervise junior staff
  • Ability to resolve project-related problems and prioritizes workload for self and team
  • Ability to work within a project team
  • Works efficiently and effectively in a matrix environment

 Preferred:

  • 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
  • Local project coordination and/or project management

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