Sr CRA I/II (Madrid)

Sr CRA I/II (Madrid)

13 ago
|
Thermo Fisher Scientific
|
Madrid

13 ago

Thermo Fisher Scientific

Madrid

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.

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 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. Participates in the investigator payment process.
Ensures a shared responsibility with other project team members on
issues/findings resolution. Investigates and follows-up on findings as
applicable
• Provides trial status tracking and progress update reports to the Clinical
Team Manager (CTM) as required. Ensures study systems are updated per agreed
study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC
check of reports generated from CTMS system where required.
• Participates in investigator meetings as necessary. Identifies potential
investigators in collaboration with the c

📌 Sr CRA I/II (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid

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