Senior Clinical Research Associate

We’re looking for a Senior Clinical Research Associate 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) 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 by 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 and passport as required

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people who genuinely care about one another, our clients, and our mission of furthering research to improve patients’ lives in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, and One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and speciality pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities to have the tools they need to succeed.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff to think creatively, challenge ideas, and solve complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.We hire people that add to our culture and then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.