20 oct
|
ThermoFisher Scientific
|
Madrid
20 oct
ThermoFisher Scientific
Madrid
Environmental Conditions
Office
Competitive sign-on bonus considered for qualified candidates
Join Us as a Clinical Research Associate – We're hiring CRA (Level II) to CRA (Level II) in Madrid and Barcelona , Ideal candidates will have independent monitoring experience.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our integral team, you’ll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being,
and data reliability. Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with the approved monitoring plan
📌 Senior Clinical Trial Administrator (Madrid)
🏢 ThermoFisher Scientific
📍 Madrid