Premier Research is looking for a Freelance / Contract Senior CRA with recent experience in Oncology and ideally experience also in medical devices and rare disease studies. The successful contractor will join our Clinical Monitoring team with an immediate start date and a contract duration of 6 months.
Ideally located in Milan, we can consider either a 0.8 or full FTE. The successful freelancer will perform, on average 4-5 site monitoring visits per month (dependent on Clinical Monitoring Plan).
The sites are located across Italy and include the following cities. Milan, Pisa, Catania, Rozzano, Firenze, Torino, Massa, Terni, Naples and Roma.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
We are Built by You. Your ideas influence the way we work, and your voice matters here.
We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Together, we are Built for BiotechSM. Join us and build your future here.
What You’ll Be Doing:
- Conducting Monitoring visits such as (Qualification, SIV, RMV and COVs)
- Site management
- Supporting upcoming database lock
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.
- Reviews site documents and verifies they are accurate, complete, current, and include required updates.
- Maintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.
What We Are Searching For:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Previous clinical research experience required, completion of CRA training program
- Experience in monitoring complex trials or global trials or equivalent experience
- Experience in Oncology studies required
- Ability to share documents, certifications and training logs to demonstrate compliance with the Ministerial Decree.
Why Choose Premier Research?
Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, 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 specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving 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, 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.
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