CRA I / CRA II, FSP

🔥 12 minutes ago

🇩🇰 Denmark – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 15%

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.

Apply Now

Find Similar Remote Jobs

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 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 sponsor/monitoring procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions • Ensure data accuracy through source data review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and make compliance recommendations • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical trial management systems according to study conventions • 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/tools and contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Valid driver's license where applicable • CRA experience with CNS/Alzheimer’s disease • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 and attention to detail • Good 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 • Ability to work in office, laboratory, clinical and/or home office environments • Ability to travel frequently to site locations

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Frequent travel generally 60–80%, including potential extended overnight stays • Personal protective equipment provided/required, including protective eyewear, garments and gloves

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume