CRA II/Senior
Syneos Health
Greece- GRC-Vrilissia-Ethnikis-Antista
πριν από 6 μέρες

JOB SUMMARY

The Senior Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative / physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-

GCP, and all applicable local and federal regulatory requirements.

JOB RESPONSIBILITIES

  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-
  • GCP and / or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.

  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject / patient as required / appropriate.
  • Per the Clinical Monitoring / Site Management Plan (CMP / SMP) :
  • oAssesses site processes

    oConducts Source Document Review of appropriate site source documents and medical records

    oVerifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records

    oApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

    oUtilizes available hardware and software to support the effective conduct of the clinical study data review and capture

    oVerifies site compliance with electronic data capture requirements.

  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).
  • Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan / Site Management Plan.
  • Supports subject / patient recruitment, retention and awareness strategies.Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.

  • Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.
  • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
  • Prepares for and attends Investigator Meetings and / or sponsor face to face meetings when required
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • Qualifications

    QUALIFICATION REQUIREMENTS

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements
  • Previous experience (min. 1 year) in monitoring oncology studies is mandatory.
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Fluent English and Greek language skills (both written and spoken).
  • Ability to manage required travel of up to 75% on a regular basis
  • Disclaimer :

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

    Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

    The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

    Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.

    Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

    LI-MR1

    Please be aware only selected candidates will be contacted back.

    Why Syneos Health? Join a game-changing company that isreinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

    Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.

    You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past.

    Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-

    deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

    Στείλτε την αίτηση σας
    Προσθήκη στα αγαπημένα
    Κατάργηση από τα αγαπημένα
    Στείλτε την αίτηση σας
    Το e-mail μου
    Πατώντας στο κουμπί «συνέχεια», δίνω στο neuvoo τη συγκατάθεση μου να καταχωρήσει τα δεδομένα μου και να μου στέλνει ειδοποιήσεις μέσω email, όπως αναφέρεται λεπτομερώς στην πολιτική προστασίας προσωπικών δεδομένων του neuvoo. Μπορείτε ανά πάσα στιγμή να αποσύρετε τη συγκατάθεση σας ή να διαγραφθείτε οποιαδήποτε στιγμή.
    Συνέχεια
    Φόρμα αίτησης