Senior CRA – FSP

🕒 October 19

🇵🇪 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

• Monitor assigned clinical study sites independently across all study stages and phases • Contribute to investigator and site selection • Support study start-up and regulatory maintenance, including site qualification visits and submissions to EC/IRB and regulatory authorities • Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles • Confirm required site training completion and inspection readiness • Participate in Local Study Team meetings and National Investigators meetings as applicable • Initiate, monitor, and close study sites • Share patient recruitment and site performance information with the Local Study Team • Drive site performance, resolve study-related issues, and escalate issues appropriately • 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 Source Data Review, CRF review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity • Ensure timely data query resolution and robust 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 • Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues • Assist sites in 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 completion of the local eTMF • Provide local-market research information 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 perform clinical study monitoring, including remote and onsite visits • Experience with CTMS and other study systems • Knowledge of study supplies, drug accountability, and drug destruction procedures • Ability to perform Source Data Review, Case Report Form review, and Source Data Verification • Ability to manage data queries and Serious Adverse Event reporting • Ability to prepare monitoring visit reports and maintain essential study documentation • Ability to support audits and regulatory inspections • Ability to comply with AstraZeneca policies, procedures, legislation, and Code of Ethics

🏖️ Benefits

• Full-time employment • Fully remote work arrangement

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