Senior CRA – FSP

🕒 October 15

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Contribute to the selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification visits and submission of documents to EC/IRB and Regulatory Authorities where required • Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles • Confirm required site-staff training completion and maintain inspection readiness • Participate in Local Study Team meetings and National Investigators meetings as applicable • Initiate, monitor, and close study sites in compliance with procedural documents • Share patient recruitment and site progress information within the Local Study Team • Drive site performance and resolve or escalate study-related issues • Update CTMS and other systems with study-site data • Manage study supplies, drug supplies, and drug accountability • Perform remote and onsite monitoring visits and remote data checks • Perform SDR, CRF review, and SDV according to the Monitoring Plan • Conduct site quality risk assessments and adapt monitoring intensity • Ensure timely data-query resolution and collaborate with data management on study-data quality • Ensure accurate and timely reporting and follow-up of Serious Adverse Events • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality, privacy, compliance, and ICH-GCP issues • Assist sites with maintaining inspection-ready investigator site files • Support 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 eTMF completion • Provide local-market research information on sites, investigators, and competing studies • Ensure compliance with AstraZeneca’s Code of Ethics, policies, procedures, and applicable legislation • 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 • ICH-GCP training and compliance knowledge • Knowledge of applicable local, national, and regional regulations • Ability to use CTMS and other study systems • Ability to perform Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV)

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule

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