FSP CRA, Level II

🕒 September 9

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 20%

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 or 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 • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify process failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and CRF review • Assess investigational product through inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigational sites between monitoring visits and follow issues through resolution • Conduct supervising tasks according to the approved monitoring plan • Participate in investigator payments, meetings, site identification, site initiation, trial closeout, and retrieval of 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 such as the Clinical Trial Management System • Facilitate communication among investigational sites, the client company, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks including 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 OR Registered Nursing certification or equivalent and 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 • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills

🏖️ Benefits

• annual incentive plan bonus • healthcare • Range of employee benefits • Career and development prospects • Innovative, forward-thinking organization • Exciting company culture centered on integrity, intensity, involvement, and innovation • Accessibility assistance or accommodation during the job application process for job seekers with disabilities

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