Senior CRA Oncology - Single Sponsor - Italy
TFS, Italy
Job Description
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
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
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
Contribute to the completion of the application to Ethics Committee/IRB, prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager
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
**We are looking for candidates belonging to protected categories under art. 1 L. 68/99.**
Requirements
Bachelor’s Degree, preferably in life science or nursing; or equivalent
Over 3 year experience working as a CRA
Experience in Oncology area
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
Excellent salary package and benefits
25 (+2) 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
Homebased equipment (teleworking)