Thermo Fisher Scientific
Thermo Fisher Scientific
Thermo Fisher Scientific izstrādā un piegādā tehnoloģijas, laboratoriju produktus un farmācijas pakalpojumus, kas atbalsta zinātnisko pētniecību un veselības aprūpi. Uzņēmuma darbība aptver dzīvības zinātņu pētniecību, analītisko problēmu risināšanu, laboratoriju darba ražīgumu, diagnostiku, kā arī terapiju izstrādi un ražošanu. Uzņēmums apkalpo klientus ar globālas komandas un zīmolu portfeļa palīdzību, kurā ietilpst Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon un PPD. Uzņēmuma karjeras iespējas aptver zinātnes, veselības aprūpes, ražošanas, loģistikas un pakalpojumu darbības, kas nodrošina šos piedāvājumus.

Clinical Research Associate (CRA) – Israel

Monitor clinical trial sites across Israel for Thermo Fisher Scientific’s PPD services, supporting protocol compliance, data quality, documentation, and audit readiness.

Apraksts

  • Coordinate clinical monitoring and site management activities.
  • Conduct remote and on-site visits to review protocol and regulatory compliance.
  • Maintain trial documentation and keep study records audit-ready.
  • Apply risk-based monitoring practices at investigator sites.
  • Identify site process issues and implement corrective and preventive actions.
  • Check data quality through source document review, source data verification, and CRF review.
  • Review investigational product inventory and records.
  • Record observations in reports and correspondence.
  • Escalate deficiencies and track them through resolution.
  • Stay in contact with investigative sites between monitoring visits.
  • Complete monitoring activities in line with the approved monitoring plan.
  • Support investigator payments and meetings.
  • Identify prospective investigators and help activate clinical trial sites.
  • Conduct trial closeout and recover trial materials.
  • Ensure essential documents meet ICH-GCP and regulatory requirements.
  • Track trial progress and provide status reports.
  • Keep study systems, including Clinical Trial Management Systems, accurate and up to date.
  • Coordinate communication among investigative sites, clients, and internal project teams.
  • Address company, client, and regulatory requirements, audits, and inspections.
  • Submit expense reports and timesheets.
  • Contribute to project publications, tools, process improvements, and other initiatives.
  • Travel more than 75%.

Prasības

  • Bachelor’s degree in a life sciences-related field.
  • At least one year of clinical monitoring experience in a clinical setting involving clinical trials, medical terminology, medical or clinical research, health care, or health sciences, with formal training in medical terminology and anatomy.
  • Valid driver’s license where applicable.
  • Equivalent qualifications may be considered through a combination of relevant education, training, and directly related experience.
  • Basic knowledge of medical or therapeutic areas and medical terminology.
  • Ability to develop and maintain working knowledge of ICH GCP, applicable regulations, and procedural documents.
  • Strong oral and written communication with medical personnel.
  • Strong interpersonal skills.
  • Customer focus, attentive listening, detail orientation, and ability to identify underlying customer concerns.
  • Good organizational and time management skills.
  • Flexibility and adaptability.
  • Developed critical thinking, root cause analysis, and problem-solving skills.
  • Ability to manage risk-based monitoring concepts and processes.
  • Ability to work independently and collaboratively.
  • Solid Microsoft Office knowledge and ability to learn relevant software.
  • Good English and Hebrew language and grammar skills.

Priekšrocības

  • Competitive salary.
  • Comprehensive benefits package focused on employee health and well-being.
  • Flexible working culture.
  • Work-life balance.
  • Award-winning learning and development program.
  • Collaborative environment with opportunities to share expertise.
  • Opportunities for professional and personal growth.

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