Senior CRA I/II – UK

🕒 4 days ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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

• Perform and coordinate all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage documentation • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs • Maintain audit readiness and collaborative relationships with investigative sites • Monitor investigator sites using risk-based monitoring, root cause analysis and corrective/preventive actions • Ensure data accuracy through source data review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payments and investigator meetings • Provide trial status tracking and progress updates to the Clinical Team Manager • Update and quality-check study systems including CTMS • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of trial materials • Maintain essential documents and conduct on-site file reviews • Assist with project publications, tools and additional study tasks • Facilitate communication between sites, clients and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to 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 • 2+ years as a clinical research monitor • Valid driver's license • Full Right to work in the UK • Fluency in English language • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and decision-making skills • Ability to handle Risk Based Monitoring concepts and processes • Effective oral and written communication skills • Customer focus, listening skills and attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work in a team or independently • Proficiency in Microsoft Office and ability to learn appropriate software • Good presentation skills

🏖️ Benefits

• Competitive sign-on bonus considered for qualified candidates • Full remote work arrangement

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