Syneos Health

Sr CRA I, Regionalizzato - Sponsor Dedicato, Milano Bergamo Brescia o Padova - Up to 10000 € Si

Location
Home Based, ITA
Salary
Competitive
Posted
24 Mar 2021
Closes
22 Apr 2021
Ref
21003897
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Clinical Research Associate I, Regionalized - Home based in Milan, Bergamo, Brescia or Padua - Up to 10000 ₠ Sign On Bonus!

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities:
• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders;
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials;
• Develop Site relationships (incl. Contract Research Organization related issue management and non- registrational /Investigator Sponsored Research Studies);
• Recommends sites during the site feasibility and/or site selection process;
• Conducts pre-study visit as appropriate;
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation;
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, Sponsor's procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable;
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions;
• Serve as a point of contact for Sites;
• Provides trainings to sites;
• Performs site closure activities when all required protocol visits and follow-up are completed;
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory;
• Ensures completeness and quality of data submitted from study sites. Ensures eCRF data is available and current by using the available systems to follow site activities;
• Oversees activities of site personnel over whom there is no direct authority;
• Motivates/influences the site to meet study objectives, including enrollment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method;
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented;
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions;
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner;
• May support Ethics Committee submission, ICF review, collection of documents to/from site;
• May support ensuring access to eDC and sponsor / vendor systems is available for clinical trial site personnel;
• May support equipment calibration and tracking;
• May support preparation of Study Initiation Visit materials;
• May support coordination and ensure database lock timelines are met as required locally.What we're looking for:
• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

• In possession of a valid CRA Certification according to the 15/11/2011 Ministerial Decree;

• 3-4 years experience in monitoring clinical trials;

• Must demonstrate good computer skills and be able to embrace new technologies;
• Excellent communication, presentation and interpersonal skills;
• Ability to manage required travel of up to 50% on a regular basis.

#LI-VC1

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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