FSP CRA – Level

🕒 October 20

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and case report form review • Assess investigational product inventory and records • Document observations and escalate deficiencies and issues through resolution • Maintain regular contact with investigative sites between monitoring visits • Conduct supervision tasks according to the approved monitoring plan • Participate in investigator payments and investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure crucial documents are complete and compliant with ICH-GCP and regulations • Conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical study systems, including the Clinical Trial Management System • 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 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 • 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 • Risk-Based Monitoring concepts and processes • Root cause analysis and problem-solving skills • Good oral and written communication skills • Good organizational and time management skills • Effective interpersonal skills • Attention to detail • Flexibility and adaptability • Ability to work independently and in a team • Microsoft Office and general digital literacy • 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 services and accommodations during the application process for job seekers with disabilities

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