Senior CRA – Level I, 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

• Deliver clinical studies at allocated sites and participate in local study teams • Collaborate with CRAs and the Local Study Team/Local Study Associate Director to achieve study commitments • Act as the main contact with study sites and monitor study conduct • Prepare, initiate, monitor, and close assigned clinical study sites • Contribute to investigator selection and national investigator meetings • Support study start-up and regulatory maintenance, including site qualification visits and submissions to ethics committees, institutional review boards, and regulatory authorities • Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles • Confirm required site staff training and inspection readiness • Initiate, monitor, and close sites; track recruitment and site performance • Drive site performance, resolve study issues, and escalate appropriately • Update CTMS and other systems with study-site data • 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 collaborate with data management on 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 and escalate serious quality, privacy, CSP, or ICH-GCP compliance issues • Assist sites in maintaining inspection-ready investigator site files • Prepare for 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 and local eTMF completion • 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 • Ability to perform advanced clinical trial monitoring • Knowledge and application of ICH-GCP, AZ Procedural Documents, SOPs, international guidelines, and relevant local regulations • Ability to train, support, and advise investigators and site staff • Ability to manage study start-up, regulatory maintenance, monitoring visits, source data review, CRF review, source data verification, quality risk assessments, data queries, safety reporting, eTMF, audits, and regulatory inspections • Compliance with AstraZeneca’s Code of Ethics, company policies, and applicable legislation

🏖️ Benefits

• Fully remote work arrangement

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