Clinical Research Associate

Premier Research Group; Polska; À distance; PLN 102 000 - 124 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life insurance

Retirement plan

Paid time off

Employee Assistance Program

Résumé du poste

Premier Research is seeking a Clinical Research Associate to join the Clinical Monitoring, Site Management and SSU team. The role supports biotech and pharma clients bringing innovative therapies to patients.

You will conduct monitoring visits, maintain TMF/eTMF, ensure data integrity and regulatory compliance, and work across remote and onsite modes in line with country regulations. Fully remote work is possible with base in central Poland.

Qualifications

• Undergraduate degree or equivalent in clinical, science, or health-related field; or licensed health-care professional; or equivalent work experience.
• Previous clinical research experience required: at least 1 year of independent monitoring.
• Experience in Neurology, Oncology, Dermatology therapy areas preferred.
• Experience supporting Phase II & III studies.

Responsabilités

• 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 monitoring modes with focus on data integrity and patient safety per country regulations.
• Plans day-to-day activities for monitoring of a clinical study and sets site priorities.
• Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits.
• Maintains TMF/eTMF per filing guidelines and understands essential documents per ICH/GCP.
• Reviews site documents to ensure accuracy, completeness, currentness, and updates.

Connaissances

Clinical monitoring

Site management

Data integrity

Regulatory compliance

Remote monitoring

Formation

Bachelor's degree in clinical/health

Outils

eTMF

Description du poste

Premier Research is looking for a 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 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 this role is 113,000 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.