Senior CRA – FSP

🕒 5 days ago

🇵🇪 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

• Take local responsibility for delivery of clinical studies at allocated sites • 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 national investigator meetings • Perform study start-up and regulatory maintenance activities where required • Train, support and advise investigators and site staff on study-related matters and RbQM principles • Confirm completion and documentation of required site staff training • Participate in Local Study Team meetings • 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 • Conduct remote and onsite monitoring visits and remote data checks • Perform SDR, CRF review, SDV and site quality risk assessments • Ensure timely data-query resolution and collaborate with data management • 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 • Escalate quality, data privacy, compliance and regulatory issues • Assist sites with inspection-ready ISFs • Support audits and regulatory inspections • Ensure essential documents are uploaded to the eTMF and ready for archiving • 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 • ICH-GCP knowledge and compliance • Ability to train, support and advise investigators and site staff • Ability to manage study start-up, regulatory submissions and maintenance where required • Ability to perform remote and onsite monitoring visits, SDR, CRF review and SDV • Ability to use CTMS and other study systems • Ability to manage study supplies, drug supplies and drug accountability • Ability to resolve data queries and work with data management • Ability to report Serious Adverse Events and follow-ups accurately and promptly • Ability to prepare monitoring visit reports and follow-up letters • Ability to support audits and regulatory inspections • Ability to manage essential documents and eTMF requirements • Compliance with AstraZeneca policies, procedures, Code of Ethics, and applicable legislation

🏖️ Benefits

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

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