Senior CRA – FSP

🕒 October 19

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 the selection of potential investigators • Support study start-up and regulatory maintenance where required, including site qualification, document preparation, and submissions to EC/IRB and Regulatory Authorities • Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles • Confirm completion and documentation of required site staff training, including ICH-GCP training • Participate in Local Study Team meetings and National Investigators meetings as applicable • Initiate, monitor, and close study sites in compliance with AstraZeneca procedures • Share patient recruitment and study site progress information within the Local Study Team • Drive site performance, identify and resolve study-related issues, and escalate issues appropriately • Update CTMS and other systems with study-site data within required timelines • Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction when applicable • Perform remote and onsite monitoring visits and remote data checks according to the study Monitoring Plan • Perform Source Data Review, Case Report Form review, and Source Data Verification • Perform Site Quality Risk Assessments and adapt monitoring intensity during the study • Ensure timely data query resolution and work with data management to maintain study-data quality • Ensure accurate and timely reporting of Serious Adverse Events and follow-ups • Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators • Follow up on outstanding site actions and ensure timely resolution • Escalate systematic or 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 • Ensure timely collection and uploading of 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 market feedback on research-related information, sites, investigators, and competing studies • Collaborate with local MSLs as directed by the LSAD or line manager • Ensure compliance with AstraZeneca’s Code of Ethics, company policies, procedures, and applicable legislation

🎯 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 and compliance knowledge • Knowledge of AZ Procedural Documents, international guidelines, and relevant local regulations • Ability to perform monitoring visits, remote data checks, Source Data Review, CRF review, and Source Data Verification • Ability to manage study supplies, drug supplies, and drug accountability • Ability to use CTMS and other study systems • Ability to ensure timely reporting of Serious Adverse Events and follow-ups • Ability to support audits and regulatory inspections • Ability to ensure compliance with AstraZeneca policies, procedures, legislation, and Code of Ethics

🏖️ Benefits

• Fully Remote work arrangement

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