Senior Clinical Research Associate / Clinical Research Associate II

44 Premier Research S.r.l.; Friuli-Venezia Giulia; In loco; EUR 52.000 - 74.000; Tempo pieno

Descrizione del lavoro

Premier Research is seeking a Senior Clinical Research Associate / CRA II to join our Clinical Monitoring, Site Management and SSU team. You will monitor sites, ensure data integrity and patient safety, and prepare for site initiation visits in line with ICH/GCP guidelines.

The role requires a degree in clinical or health-related fields, CRA training, and a minimum of 4 years of clinical trials experience for Senior CRA (and 2+ years for CRA II).

Competenze

• Undergraduate degree or international equivalent in clinical, science, or health-related field.
• Licensed health-care professional (e.g., registered nurse) or equivalent work experience.
• Completion of CRA training program and Italian Decree requirements.

Mansioni

• Delivers quality, timely monitoring reports for sponsor approval per plans.
• Maintains submission of expenses within guidelines.
• Monitors data integrity and patient safety per country regulations.
• Plans day-to-day activities for monitoring and site priorities.
• Prepares for on-site qualification, study initiation, interim and close-out visits.
• Maintains TMF/eTMF per filing guidelines.
• Reviews site documents for accuracy and updates.

Conoscenze

Clinical monitoring

GCP/ICH

CRA training

Formazione

Undergraduate degree in clinical/health

Licensed health-care professional (RN) or equivalent

Strumenti

TMF/eTMF

Descrizione del lavoro

Premier Research is looking for a Senior Clinical Research Associate / Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

What You'll be Doing:

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintains submission of expenses according to travel and expense requirements within company guidelines
• 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 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.
• Has an understanding of the required essential documents according to ICH/GCP Section 8.
• Reviews site documents and verify they are accurate, complete, current, and include required updates

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
• At least 4+ years' experience in clinical trials to qualify for a Senior CRA level and at least 2+ years' experience in clinical trials to qualify for a CRA II level.
• The required CRA certification, qualifications and training record as per the requirements of the Italian Decree.

Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. 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.

Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.