Senior CRA – FSP

🔥 2 hours ago

🇲🇽 Mexico – 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 all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation • Manage procedures and guidelines from different sponsors and monitoring environments • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Apply root-cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring • Assess investigational products through physical inventory and records review • Document observations in reports and letters; escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in the investigator payment process and share responsibility for issue and finding resolution • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform required CTMS report quality checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites in collaboration with the client company • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and in place; conduct on-site file reviews • Assist with project publications/tools and contribute ideas to the project team • Perform additional study tasks assigned by the CTM, such as trip report review, newsletter creation, and leading CRA team calls • Facilitate communication between investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to project work and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and 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 • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills, including communication with medical personnel • Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues • Effective interpersonal skills • Strong attention to detail • Effective organizational and time management skills • Flexibility and adaptability • Ability to work in a team or independently • Proficient knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Frequent driving to site locations and frequent travel, generally 60–80% • Ability to comply with specific sponsor/client/site requirements • Personal protective equipment required, including protective eyewear, garments, and gloves

🏖️ Benefits

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

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