Clinical Research Associate

We’re looking for a Clinical Research Associate II or Clinical Research Associate I to join our Clinical Data Sciences team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.The position can be home-based, office-based (Milan, Italy) or a hybrid mix.

RESPONSIBILITIES

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
• Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
• Monitors with knowledge of quality/scope/timeline and budget parameters
• Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.

REQUIREMENT

• Undergraduate degree or local equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse)
• Previous clinical monitoring experience as a CRA
• Fluency in English and local language
• Previous experience in clinical trials
• Excellent team player, collaborative and able to enable an effective team
• Ability to multitask and work effectively in a fast-paced environment with changing priorities
• Strong verbal and written communication skills
• Excellent organizational and time-management skills, able to meet deadlines
• Valid driver’s license, passport as required

Average Salary: € Negotiable

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