Covance

Clinical Research Associate II

MX
Job Number
2017-15737
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

Covance is seeking office based Clinical Research Associates (CRAs) in Mexico City, Mexico! 

Sign-on bonus is available!

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.

As a Clinical Research Associate (CRA) at Covance you will be working on critical clinical trials for large, prominent pharmaceutical companies. You will conduct site monitoring responsibilities for clinical trials, according to Covance Standard Operating Procedures, ICH guidelines and GCP, including Pre-study, Site Initiation, Routine Monitoring and Close Out Visits. The CRA role will allow you will work on a close-knit team and be mentored by your Manager. At Covance, we know that career development is not one size fits all. We want you to not only succeed – but excel!

  • Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!  
  • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets.  
  • Join a company where people tend to stay for 6-10 years rather than 1-3
  • Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance

 

See what Covance CRAs have to say:

“The opportunities to grow are one of the top things I like about Covance. Covance really allows you to find a place to be happy. The flexibility of opportunities with Covance is just wonderful."

"One of the things that attracted me to Covance was its longstanding reputation as an industry leader. I consistently hear from sites that Covance is one of their preferred CROs to work with, which speaks volumes about the company’s reputation.”

Visit Covance's CRA microsite to learn more about being a CRA at Covance: https://inside.covance.com/careers-cra-jobs-clinical-research-associate

Education/Qualifications

Minimum Required:

  • External Candidates
    • 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 2 years of Clinical Monitoring experience.
  • Internal Candidates
    • Internal candidates with a minimum of 2 years of Clinical Monitoring experience
    • 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
    • Preferred: thorough knowledge of Covance SOPs for site monitoring

Experience

Additional Responsibilities & Experience Include:

  • 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
    • 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
    • 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
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare accurate and timely trip reports
  • 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
  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
  • Complete 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, of new employees, e.g. co-monitoring
  • Coordinate 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
  • 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
  • Preferred:
    • One (1) or more additional years of experience in a related field (i.e. medical, clinical,
      pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred

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