Website Premier Research Group Limited
Clinical Research Associate
Lendlease
Job Description
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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