Covance

Senior CRA (Home based or Office based) - Early CD

Job Location(s) IT-Rome | IT-Rome
Job Number
2017-16408
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

We are currently looking for talented Senior Clinical Research Associate to join our Early Clinical Development department in Italy. We are proud to have an outstanding team of the best professionals on the market and are looking for people who are ready to show great performance and interest in Clinical Trials.


You will become a part of our team who is always ready to help. 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.

 

Responsibilities:

  • Participates in initial and on-going protocol and CRF training at study site
  • May serve as the Primary contact for the clinical sites/Sponsor
  • Participates in the generation of study specific monitoring plans
  • May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Visits
  • Participates in Sponsor and Investigator/Initiation Meetings
  • Tracks progress of assigned studies/projects and identifies appropriate actions to achieve target objectives.
  • Fulfils general on-site Monitoring Responsibilities
  • Prepares accurate and timely trip reports.
  • Identifies and completes follow- up of SAEs at study site for which he/she is responsible
  • Independently performs CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems.
  • Assists with training of new employees, e.g. co-monitorin

Education / Qualifications

  • University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
  • Thorough knowledge of ICH guidelines, GCP and the clinical trial process
  • Knowledge of the drug development process.
  • Proficient computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
  • Excellent verbal and written communication skills
  • Valid Driver’s License

 

Experience

  • 3-4 years of experience in a related field, including 2-3 years of independent on-site monitoring in CRO or Pharma
  • Experience with Phase I and PoC Studies

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