Clinical Research Associate - Site Start-Up Segrate

Clinical Research Associate - Site Start-Up
Segrate
Lombardia, Segrate

JOB DESCRIPTION**:**Clinical Research Associate (Site Start-Up) - Home-based, Italy or Office-based, Milan (€10k joining bonus)

We are vital links between an idea for a new medicine and the people who need it.

We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.

You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our global Clinical Monitoring department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools.

Together, we help clients define and develop clinical programmes, minimise delays and execute high-quality, cost-efficient clinical studies.

As a Clinical Research Associate working in the Start Up team, you will:

- Perform and coordinate site evaluation visits in accordance with ICH, GCP and FDA guidelines, as well as SOP's to ensure the selection of appropriately qualified sites of investigational products and/or medical devices.

- Work in conjunction with the Country Approval Specialist(s) and Contract Specialist(s) to prepare investigational sites for activation.

- Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, challenging projects.

- Have excellent communication and interpersonal skills and are looking to work in a collegiate environment where you want to take true ownership for your work.

- Perform and coordinate all aspects of the clinical monitoring process.

You shall also be qualified to conduct monitoring activities independently.

- Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.

**Job Qualification**:

To be considered for this position you should have the following Education and Experience:

- Certified according to the Italian CRO Decree - essential.

- University degree in a life-sciences field.

- Minimum 2+ years of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation, to include conduction of qualification, initiation, monitoring and close out visits with a particular emphasis on qualification visits.

- Demonstrated understanding of ICH-GCP, EU and FDA requirements.

- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.

- Exceptional communication, collaboration, organisational and time management skills.

- Fluency in both Italian and English languages is essential.

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team.

We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.

We have a flexible working culture, where PPD clinical research services truly value a work-life balance.

We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together.

We are a global organization but with a local feel.

Our 4i Values:

Integrity - Innovation - Intensity - Involvement

**Diversity Statement**:

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect.

PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.