CRA II/Sr CRA I/Sr CRA II – Multiple Therapeutic Areas

🕒 October 21

🐊 Florida – Remote

🐊 Florida – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Perform and coordinate all aspects of the clinical monitoring and site management process • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation • Manage procedures and guidelines from different sponsors and monitoring environments, including FSO, FSP, and Government • Act as a site processes specialist • Ensure trials are conducted according to approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects' rights and well-being and ensure data reliability • Ensure audit readiness • Develop collaborative relationships with investigational sites • Perform frequent drives to site locations and travel, generally 60–80%, potentially including extended overnight stays • Work in office, laboratory, clinical, and/or home office environments • Use required personal protective equipment when exposed to biological fluids or potentially infectious organisms

🎯 Requirements

• Bachelor's degree in a life science related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • 1–2 years of traveling on-site monitoring experience • Therapeutic experience in at least one of: Oncology, Ophthalmology, Neurology, Cardiology, Rare Disease, Respiratory, Obesity, and/or Pulmonary • Valid driver's license where applicable • Must live within 60 miles of the nearest major airport • Up to 80% travel expected • Must be legally authorized to work in the United States without sponsorship • Must pass a comprehensive background check, including drug screening • 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 • Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues • Organizational and time management skills • Interpersonal skills • Flexibility and adaptability • Ability to work independently or as part of a team • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Presentation skills

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Professional development through exposure to multiple sponsors, monitoring environments, and therapeutic areas

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