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Job Details

CRA II/Senior Italy, Home Based

Company: Syneos Health
Location: Italy
Reference: 17004893
Closing Date: 05 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

Here at Syneos Health we are currently recruiting for a CRA to be based in Italy

Requirements:

Here at Syneos Health we are currently recruiting for a CRA to be based in Italy

Position Overview

As a key member of our Clinical Monitoring team you will be responsible for all clinical monitoring activities following study guidelines, SOPs, and applicable regulations.  Travel will be across the country with a maximum expectation of eight days on site per month.   Supported by a local Line Manager, we can also offer you the opportunity to be sponsor dedicated and therapeutically aligned providing specialised career development.

Responsibilities

Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements

Mentor CRAs on monitoring, internal procedures, and query resolution

Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training

Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations

Evaluate overall performance of site and site staff

Ensure compliance and understanding of study requirements by site staff

Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff

Interpret data to identify protocol deviations or major risks to data integrity

Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines

Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions

Review and verify case report forms and other clinical data for completeness and accuracy

 

Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations

Generate queries and manage resolutions with site staff

Maintain project tracking systems as required

Participate in the identification and selection of investigators and clinical sites

Assist in the development of study specific monitoring procedures and guidelines

Mentor junior staff on training, guidelines, and processes

Complete assigned training programs and apply learning

Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations

Qualifications/Requirements

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

Prior clinical monitoring experience

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Strong organizational skills

Must demonstrate good computer skills

Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

We have a comprehensive benefits package and offer highly competitive remuneration.


If you have the required experience for this position and are eligible to work in the required location then please apply by CV

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

 

 

Apply for this job: CRA II/Senior Italy, Home Based

Contact Information:

Address:  Spain
Calle Hernani, 59-3 (edificio Cubik) 28020 Madrid Spain

Spain
Website:  Visit Our Web Site

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