Premier Research - CRA Trainee

Employer:
Domain:
  • Pharmacy - Health
  • Job type: full-time
    Job level: Student/Graduate
    Location:
  • BUCHAREST
  • Updated at: 22.11.2016
    Short company description

    Requirements

    You'll need this to be considered:

    Undergraduate degree or its international equivalent in clinical, science
    Previous clinical research experience and/or completion of CRA training program is mandatory
    Fluent in English and Romanian- verbal and written
    Knowledge of ICH / GCP regulations
    Knowledge of web based communication tools for conferences and any other IT systems required for the job
    Excellent team player, collaborative and able to enable an effective team
    Ability to multitask and work effectively in a fast-paced environment with changing priorities
    Excellent organizational and time-management skills, able to meet deadlines
    Customer service focused in approach to work, both internally and externally
    Valid driver’s license, passport as required

    Responsibilities

    Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.

    We’re looking for a talented and energetic CRA Trainee to join our team! This is an exciting opportunity to join the team in our office in Bucharest, Romania.


    You will be accountable for:

    Delivering quality, timely monitoring reports for sponsor approval
    Scheduling site visits for monitoring
    Maintaining submission of expenses
    Ensuring the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites
    Monitoring (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
    Planning day to day activities for monitoring of a clinical study and sets priorities per site
    Preparing for and conducting on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
    Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF)
    Assisting project team with assessing project feasibility and recruitment
    Maintaining project tracking system of subjects and site information
    Ensuring adherence to study timeline and budget