CRA II/Sr CRA – Multiple Therapeutic Areas

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🐊 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 clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs • Protect subjects' rights, well-being and data reliability • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Perform root cause analysis, identify corrective/preventive actions and resolve site deficiencies • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product through inventory and records review • Prepare monitoring reports and letters; escalate and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and make recommendations on site acceptability • Perform trial closeout and retrieve trial materials • 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 management systems • Facilitate communication among investigative sites, client companies and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications and tools and 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 • Approximately 1 year of experience as a clinical research monitor, or completion of PPD Drug Development Fellowship • Equivalency of appropriate education, training and/or directly related experience may be considered • Valid driver's license where applicable • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations and procedural documents • Risk-Based Monitoring concepts and processes • Critical thinking, root cause analysis and problem-solving skills • Good oral and written communication skills • Organizational and time management skills • Interpersonal skills and attention to detail • Ability to work flexibly and adaptably in varied scenarios • 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 • Good presentation skills • Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays

🏖️ Benefits

• Fully remote work arrangement • Frequent travel expenses implied by required site travel • Personal protective equipment such as protective eyewear, garments and gloves

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