FSP CRA, Level II

🔥 9 hours 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 and on-site visits to assess protocol and regulatory compliance • Manage required 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 data review, source data verification and CRF 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 • Conduct supervising tasks according to the approved monitoring plan • Participate in investigator payment processes and resolve project team issues/findings • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and make compliance recommendations • 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, including Clinical Trial Management Systems • 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/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 • 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 • Digital literacy and solid knowledge of Microsoft Office • 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 accommodations during the application process for job seekers with disabilities

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