FSP CRA, Level II

🕒 6 days ago

🇨🇳 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 or 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 source document review, source data verification, and case report form review • Assess investigational product through physical inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow up on issues • Participate in investigator meetings and identify potential investigators with client companies • Initiate clinical trial sites and make recommendations regarding compliance • Perform trial closeout and retrieve trial materials • Ensure crucial documents are complete according to ICH-GCP and applicable regulations • Conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as Clinical Trial Management Systems • Facilitate communication among investigative sites, client companies, 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/tools and contribute ideas to the project team • Contribute to process improvement initiatives and other project work

🎯 Requirements

• Bachelor's degree in a life sciences related field or a 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, including communication with medical personnel • Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently and in a team • Solid knowledge of Microsoft Office 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 organization and outstanding career and development prospects • Company culture emphasizing integrity, intensity, involvement, and innovation • Accessibility services/accommodations for job seekers with disabilities during the application process

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