Job Description
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
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. 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
Experience in monitoring complex trials or global trials or equivalent experience
Ideally experience of working within Neurosciences and Oncology
Monitoring will mainly be in Czech Republic, however, where willing, we would like if someone can cover also Slovakia and, to this regard, they should have some knowledge of the local language. This last requirement is desirable vs essential.
This is a contract position offered as a 0.6 FTE for a contract duration of up to a year.