Senior Clinical Research Associate – FSP

🕒 October 20

🇵🇪 Peru – 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 selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification, regulatory document preparation, tracking, and submissions where required • Train, support, and advise investigators and site staff on study-related matters and RbQM principles • Confirm required site-staff training completion and maintain inspection readiness • Participate in Local Study Team and National Investigators meetings • Initiate, monitor, and close study sites • Drive site performance and resolve or escalate study-related issues • Update CTMS and other systems with study-site data • Manage study, drug, and drug-accountability supplies • Perform remote and onsite monitoring visits, remote data checks, SDR, CRF review, and SDV • Conduct site quality risk assessments and adapt monitoring intensity • Ensure timely data-query resolution and collaborate with data management on data quality • Ensure accurate and timely reporting of Serious Adverse Events and follow-ups • 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 • Ensure timely collection and uploading of essential documents to the eTMF and support QC checks • Prepare study documents for final archiving and completion of the local eTMF • Provide local-market feedback on research information, sites, investigators, and competing studies • Ensure compliance with AstraZeneca 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 travel internationally as required • Valid driving license • Ability to perform advanced monitoring and potentially take on LST tasks • Compliance with AZ Procedural Documents, ICH-GCP, and relevant local regulations

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