Clinical Research Associate II

Premier Research; Deutschland; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Premier Research is seeking a 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 into new medicines and devices, while ensuring patient safety and data integrity.

Responsibilities include delivering monitoring reports, coordinating site visits, managing TMF/eTMF, and ensuring compliance with ICH/GCP.

Qualifikationen

• Undergraduate degree or equivalent in clinical, science, or health field.
• Previous CRA experience is required.
• This position requires current working rights for Australia.

Aufgaben

• Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines.
• Maintain submission of expenses according to travel and expense requirements within company guidelines.
• Monitor (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.
• Plan day-to-day activities for monitoring of a clinical study and set priorities per site.
• Prepare for and conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required by the clinical monitoring plan.
• Maintain TMF/eTMF per filing guidelines and ensure essential documents are current and updated.

Ausbildung

Undergraduate degree in clinical/science/health-related field

Tools

eTMF system

Jobbeschreibung

Premier Research is looking for a 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:

• Deliver quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintain submission of expenses according to travel and expense requirements within company guidelines
• Monitor (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Plan day-to-day activities for monitoring of a clinical study and sets priorities per site
• Prepare for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintain Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Understand the required essential documents according to ICH/GCP Section 8. Review 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 experience as a CRA required

This position requires current working rights for Australia.