Premier Research
biotech, medtech, and specialty pharma
ClinicalResearchAssociateII
“Clinical Research Associate II at Premier Research. Skills: monitoring, data integrity, patient safety, TMF/eTMF maintenance, site document review. 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”
What You'll Achieve.
Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
Industry & Context.
Monitoring will mainly be in Czech Republic, however, where willing, we would like if someone can cover also Slovakia
What They're Looking For.
Must Have
Previous clinical research experience required, completion of CRA training program, Experience in monitoring complex trials or global trials or equivalent experience, Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited a licensed health-care professional (i. e. , registered nurse); or equivalent work experience required
Nice to Have
Ideally experience of working within Neurosciences and Oncology, some knowledge of the local language [Slovakia]
What You'll Do.
timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
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
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
Reviews site documents and verifies they are accurate
and include required updates
How You'll Work.
Team & Collaboration
cross-functional coordination
Process & Methodology
Plans day to day activities for monitoring of a clinical study and sets priorities per site
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