FSP CRA, Level II

🕒 September 9

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 21%

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 documentation and sponsor or supervising-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Apply risk-based monitoring, 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 products 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 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 conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including Clinical Trial Management Systems • Facilitate communication among investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets • Assist with project publications and tools and contribute to process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences-related field, 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 • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills • Customer focus, listening skills, attention to detail, and ability to perceive underlying issues • Organizational and time management skills • Interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Digital literacy, including Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Presentation skills

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility services/accommodations during the job application process for job seekers with disabilities

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