Covance

  • Senior CRA - UK (Sponsor Dedicated role)

    Job Location(s) UK-Maidenhead
    Job Number
    2018-19844
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    Covance is looking for a Senior CRA with at least 4 years of monitoring in the UK to be client dedicated with one of key customers.

     

    Responsibilities:

     

    Investigative site management and monitoring

    Demonstrate commitment to quality in all aspects of monitoring; ensure ethical conduct of clinical studies; adhere to study monitoring instructions/conventions, write reports within the timeframe agreed at study start, conduct Feasibility assessment, Site Selection Visit, Site Initiation Visit, Monitoring Visits and Close-Out visit at investigative sites; regular review of Investigator Site Files and ensure that the ISF reconciliation with the Trial Master File is conducted; ensure proper handling of study drugs; perform study drugs accountability; ensure site inspection readiness; ensure site performance (recruitment) as planned; monitor and track the informed consent process; perform safety reviews/SAE reconciliation and assure appropriate action is taken at the investigative site in accordance with the appropriate policies and SOPs, as well as ICH-GCP guidelines and local regulations. 

     

    • Ensure data integrity

    Conduct Source Document Verification of CRF data against medical records/pharmacy records, etc. to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with Clinical Development Data Management in order to improve data quality; ensure issues relating to data quality are escalated and resolved with the study team

    • Train and assist investigative sites

    Attend CRA and Investigator meetings; if required, assist with training of investigative site personnel in GCP and local regulations and ensure sites are conducting Actelion’s clinical research according to the protocol, local regulatory requirements and other appropriate regulations; build relationships with site staff at assigned sites. Assist in the preparation for site audits and inspections and in responding to any issues identified within the timeframe specified.

    • Communication

    Identify site issues and ensure resolution, escalating issues if necessary; create and submit monitoring reports within the timeframe agreed at study start, confirmation/follow-up correspondence and telephone contacts for assigned sites and send documents to study team as required; respond to audit findings; adhere to proper lines of communication attend and participate in study team meetings/teleconferences as well as country meetings/teleconferences; ensure information in the CTMS is up to date

    • Development

    Keep medical and clinical knowledge for assigned therapeutic areas up to date; mentor/coach new CRAs; maintain annual training records

    • Regulatory Documentation

    Collecting regulatory documentation (when required), maintain required documentation in the Investigator Site File and provide required documentation from site for the Trial Master File according to quality standards.

    • Audits/Inspections

    Support in responding to company, client and federal regulatory requirements/audits

    Education / Qualifications

    • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),
    • a minimum of 4 years of Clinical Monitoring

     OR

    • In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring experience

    Experience

    • 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

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