Principal CRA

🔥 8 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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

• Manage and coordinate all aspects of clinical monitoring and site management • Perform remote and on-site monitoring activities using a risk-based monitoring approach • Conduct Source Data Review, Source Data Verification, and CRF review as applicable • Assess investigational product accountability through inventory and records review • Identify site process issues and implement corrective and preventive actions • Identify, document, escalate, and follow through on site deficiencies and issues until resolution • Maintain communication with investigational sites between monitoring visits • Ensure trials follow approved protocols, ICH-GCP, applicable regulations, SOPs, and procedures • Ensure essential study documents are complete, accurate, and maintained according to regulatory requirements • Conduct on-site file reviews and support audit and inspection readiness • Initiate clinical trial sites and support site close-out activities • Participate in investigator meetings and support identification and assessment of potential investigational sites • Respond to company, sponsor, and regulatory audit and inspection requirements • Provide study status and progress updates to the Clinical Team Manager • Maintain accurate and timely information in study systems, including CTMS • Perform quality checks of CTMS-generated reports • Facilitate communication between sites, sponsors, and project teams • Contribute to project tools, communications, publications, process improvements, and best-practice sharing • Support additional study activities such as trip report reviews, newsletters, or leading CRA team calls • Participate in investigator payment processes • Complete expense reports and timesheets accurately and on time

🎯 Requirements

• Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or equivalent relevant academic/vocational qualification • At least 2+ years of experience as a Clinical Research Monitor / CRA, or comparable relevant experience • Valid driver's license, where applicable • Equivalent combinations of education, training, and directly related experience may also be considered • Strong clinical monitoring and site management skills • Excellent understanding and practical application of ICH-GCP, applicable regulations, and clinical research procedures • Good knowledge of medical terminology and relevant therapeutic areas • Experience applying Risk-Based Monitoring (RBM) principles and processes • Strong critical thinking, root-cause analysis, and problem-solving capabilities • Excellent attention to detail with strong organizational and time-management skills • Effective written and verbal communication skills, including the ability to communicate confidently with medical professionals and investigational site staff • Strong interpersonal skills and a collaborative, customer-focused approach • Ability to adapt to changing priorities and work effectively both independently and as part of a global team • Proficiency in Microsoft Office and the ability to quickly learn clinical trial systems and software • Good written and spoken English • Strong presentation skills • Ability to travel frequently, typically 60–80% • Ability to drive regularly to clinical trial sites • Ability to undertake extended and overnight stays when required • Compliance with applicable sponsor, client, and investigational site requirements

🏖️ Benefits

• The opportunity to work on innovative and diverse global clinical research programs • Exposure to a broad range of sponsors, therapeutic areas, and clinical trial environments • A collaborative and inclusive culture where your expertise and ideas are valued • Continuous learning, professional development, and opportunities for career progression • Competitive compensation and benefits • Appropriate personal protective equipment provided or required for exposure to biological materials