FSP CRA I / CRA II – Multiple Therapeutic Areas

🔥 0 minutes ago

🤠 Texas – Remote

infoinfo

⏰ Full Time

🟢 Junior

🧪 Clinical Research

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 sponsor-specific procedures and guidelines • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs • Protect subjects’ rights and well-being and ensure data reliability • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Participate in investigator meetings and investigator payment processes • Initiate qualified clinical trial sites and perform trial closeout and material retrieval • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status and progress reports to the Clinical Team Manager • Update clinical trial systems according to study conventions • Facilitate communication among investigative sites, sponsor and project teams • Respond to company, client and regulatory audits and inspections • Complete expense reports and timesheets • Assist with project publications, tools and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Valid driver's license where applicable • An equivalency consisting of appropriate education, training and/or directly related experience may be considered • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills, including communication with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to work in office, laboratory, clinical and/or home office environments • Ability to travel frequently and drive to site locations • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to use required personal protective equipment • Ability to work in fluctuating and/or extreme temperatures on rare occasions

🏖️ Benefits

• Fully remote work mode • Standard Monday-Friday work schedule • Frequent drives to site locations and travel generally 60–80%, including possible extended overnight stays • Personal protective equipment such as protective eyewear, garments and gloves

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