Clinical Research Associate Cochlear

7 mesi fa

Milano, Italia TFS HealthScience A tempo pieno

Overview:
**CRA ITALY - SINGLE SPONSOR - GLOBAL MEDICAL DEVICE COMPANY - SITES: PADOVA, PIACENZA, BARI**

TFS HealthScience is excited to be expanding our SRS
** **team and we are looking for an experienced, highly motivated Clinical Research Associate (CRA) in Italy who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our cores values of Trust, Quality, Flexibility and Passion are what makes TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

**Together we make a difference.**

TFS HealthScience is looking for a Clinical Research Associate in Italy.

This role will sit embedded within one of our prestigious clients (global medical device company)

who promotes rapid career development

**What can we offer you?**

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

**Country benefits include**:
Health Insurance

Lunch allowance

Home allowance

Possibility to compensate overtime

Flexibility

**Responsibilities**:
TFS Health Science is looking for a CRA (preferably experienced because of the technical complexity of the study). This role will cover the final stages of EC & CA approvals, site management, SIVs, and monitoring and close out activities for 3 sites in Italy (Piacenza, Padova and Bari).

The Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions Unit within TFS Develop and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct, according to company policies, SOPs and regulatory requirements. The CRA may conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out). Ability to travel as needed: may involve overnight and international travel.

Monitor on-site clinical trials in accordance with TFS and/or client company

Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines

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

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 applicabl

Qualifications:
Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Minimum 6months to 1 year of experience working as a CRA
- Used to working by metrics
- 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
- Ability to work independently as well as in a team matrix organization
- Excellent written and verbal communication skills.
- Excellent organizational skills
- Ability and willingness to travel
- TFS HealthScience collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the _
- privacy notice_
- for further details._
- T

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