In-house CRA (Home-based)
covance
Athens, Greece
πριν από 2 μέρες

Job Overview :

Covance by Labcorp is the drug development business of Labcorp , the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real.

Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, along with our innovative technology solutions, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve.

Covance by Labcorp has supported the pharmaceutical industry to develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.

We are currently recruiting for an In-house CRA to join our team in Greece . You will be part of our multi-sponsor structure and work with multiple vendors, drive and coordinate activities across a range of stakeholders.

You can be based anywhere in Greece as this position will be fully home-based .

Essential Duties and Responsibilities :

  • Serve as contact for project team and investigative sites, conduct site contacts and document
  • contacts for assigned sites as required per study guidelines, including creating contact reports

    for each telephone session (outbound or inbound) with sites

  • Monitor site performance and implement action plans for sites not meeting expectations in
  • conjunction with the CRA

  • Collaborate with project team and study sites during recruitment phase, tracking, patient
  • recruitment by contacting investigators as specified for the study, and discuss potential study

    risks and opportunities with the Project Manager and CTL

  • Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for
  • missing documents), resolving action items from previous visits)

  • Provide oversight and management of maintenance activities; to ensure compliance with
  • renewals, document and update according to applicable local regulatory, and IRB / IEC

    requirements.

  • Perform Case Report Form review, query generation and resolution against established data
  • review guidelines, with or without direct supervision, on Covance or client data management

    systems, as assigned by management

  • Provide oversight and management of maintenance activities; to ensure compliance with
  • renewals, document and update according to applicable local regulatory and IRB / IEC

    requirement

  • Liaise with local or central laboratories in order to ensure adherence to the protocol,
  • ensuring that all relevant documentation is current e.g., accreditation certificates, normal

    ranges, etc.

  • Assist with the coordination of study visits and shipment of drug and laboratory samples
  • Liaise with the project team and others to distribute and track clinical trial supplies, e.g.
  • Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to

    continue recruitment

  • Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate
  • within the different sections; to enter weekly details in CTMS as per study requirement

  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities, as
  • applicable in region

  • Facilitate translation and back translation of all necessary documents, as appropriate for
  • local country requirements, as needed regionally

  • Undertake other project related administrative tasks (i.e. recruitment tracking, site document
  • preparation) as appropriate, as assigned by the Project Manager and CTL; might be requested

    to work in a client facing environment

    Education / Qualifications :

  • University or college degree (biological or life science preferred), or certification in a
  • related allied health profession from an appropriately accredited institution (e.g., nursing

    licensure, medical or laboratory technology)

    Experience :

  • Minimum of 2 years of industry experience in a related role (e.g. site management, inhouse CRA, study coordinator, research nurse, site pharmacist etc.)
  • Previous experience in remote or on-site visits highly preferred
  • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH
  • Guidelines and GCP

  • Ability to work within a project team
  • Good planning, organization, time management and problem solving skills
  • Fluent in Greek and English
  • Αναφορά αυτής της εργασίας
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