Clinical Research Associate II - Poland

61 Premier Research Poland Sp. z.o.o; Polska; Remote; PLN 129,000 - 157,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Clinical Research Associate II to join our Poland team in Clinical Monitoring, Site Management and SSU. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas into new medicines and diagnostics, with a focus on data integrity and patient safety.

This remote-friendly role requires an undergraduate science degree or equivalent and licensure as a health-care professional or equivalent experience.

Qualifications

• Undergrad degree or international equivalent in clinical, science, or health-related field.
• Licensure as a health-care professional (e.g., registered nurse) or equivalent work experience.
• 1 year of independent monitoring experience preferred.
• Experience in Phase II/III studies across multiple therapy areas is a plus.

Responsibilities

• Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Maintains submission of expenses according to travel and expense requirements.
• Monitors remotely, onsite, or other approved modes with focus on data integrity and patient safety.
• Plans day-to-day monitoring activities and sets site priorities.
• Prepares for and conducts monitoring visits at investigator sites as required by the plan.
• Maintains TMF/eTMF per company guidelines and filing rules.
• Understands essential documents per ICH/GCP Section 8.
• Reviews site documents for accuracy and updates.

Skills

Clinical monitoring

TMF/eTMF management

ICH/GCP compliance

Data integrity

Site management

Education

Bachelor's degree in clinical/health field

Licensed health-care professional (RN)

Tools

TMF/eTMF systems

Job description

Premier Research is looking for a Clinical Research Associate II - Poland 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 to include at least 1 year of independent monitoring
• Experience working ideally across all, if not some, of the following therapy areas
• Neurology, Oncology, and Dermatology
• Experience at supporting Phase II & III studies

The role can be offered as fully remote and applications will ideally be based in central Poland.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The minimum annualized starting base pay for the CRA II is role is 143,000 PLN. The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role.

We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.

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.