CRA - MONITOR

Settore: / Farmaceutico /
Azienda: Ständler Firenze SRL
Data annuncio: 04/02/2021
Sede di lavoro: Firenze
Important CRO is looking for a Clinical Research Associate with a minimum of two years proven experience in clinical studies.

ONLY CV WITH PROVEN EXPERIENCE AS CRA WITH DM 15/11/11 CERTIFICATION WILL BE TAKEN INTO CONSIDERATION.

Role

Managing all aspects of the assigned clinical study activities on remote and site monitoring. These will include the conduction of the Initiation visits, routine monitoring, the close-out of clinical sites and maintenance of the Investigators study files;
Monitoring of the assigned study sites according to protocol regulations, SOPs, GCP and ICH guidelines;
Providing timely and accurate visit reports;
Ensuring that all the site staff involved in the study will receive accurate instructions and tools to ensure patients safety and quality data.

Requirements

Bachelor’s / Master Degree in Health, Science or equivalent
A minimum of two years’ monitoring studies experience
Certification as per DM 15/11/2011
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements, is a must.
English fluent

Personal Skills
Strong communication and leadership skills: ability to build both internal and external relationships and cooperate with all professional figures involved in the study
Ability to work under supervision
Good planning, organizational and problem solving skills
Ability to meet deadlines

Location Florence

home/office based (3/2)
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