HOME-BASED CRA en AMS Advanced Medical Services GmbH

HOME-BASED CRA
AMS Advanced Medical Services GmbH
AMS is an internationally successful and innovative Contract Research Organisation. As partner of the pharmaceutical industry we provide the whole range of expertise and capacity in the field of phase I-IV clinical trials as well as in post marketing surveillance studies and in marketing and sales services.
Barcelona, Madrid, 29 Jun.
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Descripción
AMS is looking for an HOME-BASED CLINICAL RESEARCH ASSOCIATE with MINIMUM 3 YEARS of relevant experience in clinical research monitoring in Phase II-IV, epidemiology, observational or post-marketing safety studies.
As a CRA, he/she will perform clinical monitoring activities in compliance with ICH - GCP and Regulatory requirements and will be responsible for all aspects of study site monitoring of clinical sites in SPAIN, maintenance of study files, site selection, conduct of pre-study and initiation visits and other duties. His/her tasks will also include:
• Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation
• Submission of protocol, consent documents for ethics/IRB approval and preparing regulatory submissions
• Participate in preparing and reviewing study documentation as well as feasibility studies for new proposals as required

The Clinical Research Associate must have:
- good planning, organization and problem solving abilities
- autonomy and ability to work with little direction
- good communication and interpersonal skills

Numero de vacantes: 1
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Requisitos
University degree in life science, Pharmacy, Biology or Medicine degree.
- Clinical Research Monitoring Masters/course or equivalent experience level.
- Complementary education related to Clinical Trials Monitoring, ICH Guidelines, GCP and local regulatory requirements.
- Thorough knowledge of monitoring procedures (SIV, MV, SCV, feasibilities...)
- Computer and software knowledge
FLUENCY IN ENGLISH written and verbal

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
El 60% del tiempo laboral



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