Clinical Research Associate

Overview:
TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Clinical Research Associate 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 Lombardy Region (Italy).

This role will sit embedded within one of our prestigious clients 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.

**Benefits include**:
Lunch allowance

Health Insurance

Flexible working times

Home allowance

**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/PMReview 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

Qualifications:
Bachelor’s Degree, preferably in life science or nursing; or equivalent

Minimum 1-3 years of relevant clinical experience

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
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