Senior Clinical Research Associate

46 Premier Research Group SL; España; Híbrido; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Senior Clinical Research Associate 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.

Our work improves lives and our team grows through continuous learning and collaboration. The role can be offered in remote, hybrid, or office-based settings with country-wide monitoring; average on-site days

Formación

• Undergraduate degree in clinical, science, or health-related field or licensed healthcare professional; equivalent experience.
• Previous clinical research experience required.
• At least 4+ years’ experience in clinical trials and independent monitoring.
• Dermatology experience essential; preference across all phases I–IV, though II/III only will be considered.

Responsabilidades

• 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) with focus on data integrity and patient safety per 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 visits at investigator sites as required.
• Maintains TMF/eTMF per filing guidelines and understands required essential documents per ICH/GCP.
• Reviews site documents and verifies they are accurate, complete, current, and include required updates.

Conocimientos

Clinical research

Monitoring

Site management

Data integrity

Regulatory compliance

Educación

Undergraduate degree in clinical, science, or health-related field

Descripción del empleo

Premier Research is looking for a Senior Clinical Research Associate 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. Understands the required essential documents according to ICH/GCP Section 8.
• Reviews site documents and verifies 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
• At least 4+ years’ experience in clinical trials and independent monitoring
• Dermatology experience essential Preference at working across all phases I-IV, although phase II and III only will be considered

The role can be offered as fully remote, hybrid or office based. There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.

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.