FSP CRA I / CRA II, Multiple Therapeutic Areas

🔥 21 minutes ago

⚜️ Louisiana, New Mexico, +2 more states – Remote

⚜️ Louisiana – Remote 🌶️ New Mexico – Remote 🌪️ Oklahoma – Remote 🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

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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 clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage sponsor-specific procedures and guidelines • 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 source document review, source data verification and CRF review • Assess investigational product through physical inventory and records review • 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 clinical trial sites, perform trial closeout and retrieve trial materials • Ensure essential documents are complete according to ICH-GCP and applicable regulations • Conduct on-site file reviews • Track trial status and provide progress reports to the Clinical Team Manager • Update clinical trial systems according to study conventions • Facilitate communication among 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 • Assist with project publications and tools • Contribute to project work and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and 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 • Equivalency through a combination 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 • Organizational and time management skills • Effective interpersonal skills and attention to detail • 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 • Frequent travel availability, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical and/or home office environments

🏖️ Benefits

• Fully remote work arrangement • Frequent travel, generally 60–80% • Exposure to biological fluids with potential exposure to infectious organisms • Personal protective equipment such as protective eyewear, garments and gloves

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