FSP CRA, Level II

🔥 4 hours ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🧪 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 clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and ensure audit readiness • 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 SDR, SDV and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites according to procedures and regulatory obligations • Perform trial close-out and retrieve trial materials • Ensure crucial documents are complete and conduct on-site file reviews • Provide trial status tracking and progress reports to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • Facilitate communication between 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 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 • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding 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 • Ability to communicate effectively with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work in a team or independently • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills

🏖️ Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility service and application accommodations for job seekers with disabilities

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