Senior Clinical Research Associate – 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 responsibility for local delivery of studies at allocated sites • Participate actively in local study teams and collaborate with CRAs and LSAD • Act as the main contact with study sites • Prepare, initiate, monitor, and close assigned clinical study sites • Contribute to investigator selection and national investigator meetings • Support study start-up, regulatory maintenance, and submissions to EC/IRB and regulatory authorities where required • Train, support, and advise investigators and site staff • Confirm required site training completion and inspection readiness • Monitor site performance, patient recruitment, study progress, and study-related issues • Update CTMS and other systems • Manage study supplies, drug supplies, and drug accountability • 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 accurate Serious Adverse Event reporting • Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators • Follow up on outstanding site actions and escalate quality, privacy, compliance, and regulatory issues • Assist with inspection-ready ISF maintenance 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 • Provide local research intelligence 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 training • Compliance with AZ Procedural Documents, ICH-GCP, local regulations, AstraZeneca policies, and applicable legislation

🏖️ Benefits

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

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