Senior CRA – FSP

🔥 0 minutes ago

🇨🇱 Chile – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage clinical trial documentation, procedures and sponsor/monitoring-environment guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions • Ensure data accuracy through source data review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters; escalate deficiencies and follow issues through resolution • Maintain contact with sites between monitoring visits to confirm protocol adherence and timely data recording • Track trial status and provide progress reports to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform quality checks where required • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and support trial close-out and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications/tools and perform additional study tasks assigned by the CTM • Facilitate communication between sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field OR Registered Nursing certification OR equivalent relevant formal academic/vocational qualification • Minimum of 3 years of completed on-site clinical monitoring experience • Minimum of 2 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal, organizational and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with specific sponsor/client/site requirements, including disclosure of vaccination status or other personal information when required

🏖️ Benefits

• Frequent travel, generally 60-80% but more for some individuals • Extended overnight stays may be included • Work performed in an office/laboratory/clinical/home office environment • Personal protective equipment provided/required, including protective eyewear, garments and gloves

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