Senior Clinical Research Associate

41 Premier Research Group Limited; Belo Horizonte; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Premier Research is seeking a Senior Clinical Research Associate to join our Clinical Monitoring, Site Management and SSU team. This role supports biotech, medtech and specialty pharma partners to advance life-changing science from idea to medicine, with a strong focus on patient safety and data quality.

Based in Portugal (Porto or Lisbon preferred), you will manage countrywide monitoring, prepare visits, maintain TMF/eTMF, and ensure ICH/GCP compliance.

Qualificações

• Minimum 4+ years independent monitoring experience.
• Experience across CV, oncology, rare diseases, and CNS preferred.
• Location in Porto or Lisbon with about 6 days/month monitoring travel.
• Spanish language skills highly desirable for potential Spain monitoring.

Responsabilidades

• Deliver quality, timely monitoring reports for sponsor approval per the monitoring plan.
• Submit expenses in line with travel policy.
• Conduct countrywide monitoring (remote/onsite) per country regulations.
• Plan daily monitoring activities and set site priorities.
• Prepare and conduct on-site visits at investigator sites.
• Maintain TMF/eTMF per filing guidelines.
• Ensure documents meet ICH/GCP requirements.

Conhecimentos

Clinical monitoring

Data integrity

Regulatory compliance

Formação académica

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

Completed CRA training program

Descrição da oferta de emprego

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:

• Delivering quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintaining submission of expenses according to travel and expense requirements within company guidelines
• Countrywide monitoring (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Planning day to day activities for monitoring of a clinical study and setting priorities per site
• Preparing for and conducting on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintaining 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 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, completion of CRA training program
• At least 4+ years independent monitoring
• We are looking for knowledge across a broad range of therapeutic areas so experience within at least some, if not, all of the following is needed;
• Cardiovascular, Oncology, Rare Diseases, CNS (Alzheimer's & Parkinson's Disease).
• There will be an expectation for countrywide monitoring - candidates will ideally be located in Porto & Lisbon and should be prepared for, on average, 6 days per month monitoring.
• Hospital sites are located in Lisbon, Porto and Coimbra.
• Proficiency in spoken and written Spanish highly desirable in case of a need to perform some monitoring in Spain.

This is a contract / freelance position and is offered as a full FTE with a duration of up to 1-year. It is a fully home based position.

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.

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.