Senior CRA – FSP

🔥 16 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Take local responsibility for delivery of allocated clinical studies at assigned sites • Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study commitments • Act as the main contact for study sites and monitor study conduct • Prepare, initiate, monitor, and close assigned clinical study sites • Contribute to investigator selection and, where required, study start-up and regulatory maintenance • Collect, prepare, review, track, and submit regulatory and ethics committee/IRB documents • Train, support, and advise investigators and site staff, including on Risk Based Quality Management principles • Confirm required site training completion, including ICH-GCP training, and maintain inspection readiness • Participate in Local Study Team and applicable National Investigators meetings • Drive site performance, identify and resolve study-related issues, and escalate issues as appropriate • Update CTMS and other systems with study-site data • Manage investigator site files, drug supplies, drug accountability, and drug destruction preparation • Perform remote and onsite monitoring visits and remote data checks according to the Monitoring Plan • Perform Source Data Review, Case Report Form review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity • Resolve data queries and collaborate with data management on study-data quality • Ensure accurate and timely Serious Adverse Event reporting and follow-up • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions and escalate systematic or serious quality issues • Assist sites with inspection-ready investigator site files • Prepare for and collaborate on audits and regulatory inspections • Collect and upload essential documents to the eTMF and support quality-control checks • Ensure study documents are ready for final archiving and completion of the local eTMF • 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 LST coordination or document preparation as required • Ability to travel internationally as required • Valid driving license • Knowledge and application of ICH-GCP, AZ Procedural Documents, relevant local regulations, and AZ SOPs • Ability to conduct monitoring visits, remote data checks, SDR, CRF review, and SDV • Ability to manage study supplies, drug supplies, and drug accountability • Ability to update CTMS and other study systems • Ability to ensure timely SAE reporting and data query resolution • Ability to prepare monitoring visit reports and maintain essential documents in the eTMF • Ability to support audits and regulatory inspections • Ability to ensure compliance with company policies, legislation, ethics, privacy, and safety requirements

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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