Covance

  • Sr Clin Res Assoc - sponsor dedicated

    Job Location(s) IL
    Job Number
    2018-22896
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    We are currently looking for talented Senior Clinical Research Associate to join our team in Israel. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

     

    Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

    You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.

     Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with a phenomenal team and expand your horizons feel free to reach us.

    Responsibilities:

    • All details of site management as prescribed in the project plans
    • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
    • Negotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreements
    • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
    • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems
    • 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 therequired 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
    • 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
    • Organize and make presentations at Investigator Meetings
    • 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 assignedUndertake feasibility work when requested
    • Conduct, report and follow-up on Quality Control Visits (CQC) when requested
    • 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
    • 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

    Education / Qualifications

     

    • A university or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
    • A valid driver’s license

     

    Experience

    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Excellent understanding of Serious Adverse Event (SAE) reporting
    • Ability to resolve project-related problems and prioritize workload for self and team
    • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) - minimum 4 years

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.