02 ago
|
Thermo Fisher Scientific
|
Madrid
02 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 clien
📌 Sr CRA I/II (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid