Covance

  • Senior Clinical Research Associate (SCRA)

    Job Location(s) AU-Sydney | AU-Brisbane
    Job Number
    2018-23365
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    We are seeking exceptional Clinical Research Associates at all levels based in Sydney or Brisbane, Australia to join our extraordinary people in our clinical operations team that monitors Phase I - IV clinical trials.

     

    Covance Clinical Research Associates:

    • Lead all aspects of study site monitoring according to Covance/Chiltern SOP, GCP, and ICH guidelines
    • Partner with investigators and study coordinators on pre-study qualification and site initiation visits
    • Conduct routine study site monitoring visits
    • Close-out clinical sites, and ensure study files are up to date to maintain the success of the study.

    If you are passionate about Clinical Research and a person who has experience independently monitoring Phase I - IV clinical study sites in Australia, let’s talk as we may have a job for you.

    Covance Australia is committed to providing you the flexibility to work from home, the freedom to grow & develop your career across all phases and areas of clinical trial operations, as well as provide state of the art technology and processes that help to give you time back to enjoy family life.

     

    You will join like-minded collaborative professionals at Covance who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

     

    Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.

     

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    Education/Qualifications

    Required:

    • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
    • In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
    • Thorough understanding of the drug development process
    • Fluent in local office language and in English, both written and verbal
    •  

     Preferred:

    • Thorough knowledge of Covance SOPs regarding site monitoring

    Experience

    Required:

    • Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
    • In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
    • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
    • Excellent site monitoring skills
    • Excellent study site management skills
    • Excellent 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
    • Excellent 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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