Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at
the Forefront of Innovation
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 general team, you’ll have the opportunity to perform and
coordinate all aspects of the clinical monitoring and site management process.
As a Senior Clinical Research Associate (Level 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., FSO, FSP, Government, etc.). 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.



You will ensure audit readiness and develop collaborative
relationships with investigational sites. Detailed tasks and responsibilities
assigned to your role are outlined in the task matrix.

What You’ll Do:
• Monitors investigator sites with a risk-based monitoring approach: applies
rootcause analysis (RCA), critical thinking and problem-solving skills to
identify siteprocesses failure and corrective/preventive actions to bring the
site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV
andCRF 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. Escalates observed deficiencies and issues
to clinical management expeditiously and follow all issues through to
resolution. May need to maintain regular contact

📌 FSP Sr CRA (Buenos Aires)
🏢 Thermo Fisher Scientific
📍 Buenos Aires