Clinical Research Associate - Milano, Italia - TFS

Descrizione

About TFS Health Science:

TFS HealthScience is a leading global mid-size Contract Research
Organization (CRO) headquartered in Lund (Sweden) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.


Responsibilities:

Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos, and verbal communication with Project Manager or Lead CRA
Initiates corrective action to resolve issues as directed by supervisor
Participate in contract handling and negotiation directed by Lead CRA/Project Manager
Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.
In cooperation with study team, responsible for SMF maintenance
Order, ship, and reconcile clinical investigative supplies for study sites, if applicable
Order, ship and coordination of study supplies at site
May prepare and submit status reports as directed by Lead CRA/PM
Review and support site staff to maintain SMF
Review Informed Consent documents for essential elements and protocol specifics
Update CTMS system with site and study information
May audit data in tables and text of clinical summaries
May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness
Prepare check requisitions for sponsor Project Manager approval, when applicable


Requirements:

• Bachelor's Degree, preferably in life science or nursing; or equivalent
• Over 1 year experience working as a CRA independently, CERTIFICATION already obtained.
• Able to work in a fast paced environment with changing priorities
• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines

Benefits:

working days per year of service + Paid permits
Flexible working times
TFS Academy training courses
Free Private Health Insurance
Lunch allowance for all TFS employees in Italy
Travel allowance