Senior Clinical Research Associate – FSP

🕒 October 20

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Take local responsibility for delivery of studies at allocated sites • Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study commitments • Act as the main contact with study sites • Prepare, initiate, monitor, and close assigned clinical study sites • Contribute to investigator selection • Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and Regulatory Authority submissions where required • Train, support, and advise investigators and site staff on study-related matters and RbQM principles • Confirm site staff training completion and maintain inspection readiness • Participate in Local Study Team and, where applicable, National Investigators meetings • Drive site performance, identify and resolve study issues, and escalate appropriately • Update CTMS and other systems with site data • Manage ISF, drug supplies, drug accountability, and drug destruction where applicable • Perform remote and onsite monitoring visits according to the Monitoring Plan • Perform SDR, CRF review, SDV, site quality risk assessments, and data query resolution • Work with data management to ensure study data quality • Report Serious Adverse Events and follow-ups accurately and promptly • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues • Assist sites in maintaining inspection-ready ISFs • Support audits and regulatory inspections • Collect and upload essential documents to the eTMF and support QC checks • Ensure study documents are ready for final archiving and local eTMF completion • Provide research-related market feedback on sites, investigators, and competing studies • Collaborate with local MSLs as directed

🎯 Requirements

• Minimum 3–5 years' experience as a monitor • Ability to work independently and monitor all stages of a study across different phases • Special therapeutic expertise in oncology • Ability to take on LST tasks and support the LST in coordination or document preparation as required • Ability to travel internationally as required • Valid driving license • Completion and documentation of required training, including ICH-GCP training, before and throughout the study • Knowledge of ICH-GCP, AZ Procedural Documents, international guidelines, and relevant local regulations • Ability to perform remote and onsite monitoring visits, remote data checks, SDR, CRF review, and SDV • Ability to manage study supplies, drug supplies, and drug accountability • Ability to ensure timely reporting of Serious Adverse Events and follow-ups • Ability to use CTMS and other study systems • Ability to comply with AstraZeneca policies, Code of Ethics, legislation, and SHE requirements

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule

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