Covance CRA II or Senior CRA (home based or office based) in Rome, Italy
We are currently looking for talented Senior Clinical Research Associate to join our team 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.
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
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 II, III and PoC Studies and Oncology
Job Number 2018-19232
Job Category Clinical Research Associate
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.