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 I/II, Remote Israel
Monitor clinical trial sites for Thermo Fisher Scientific’s research services team, supporting protocol compliance and accurate study records. The role combines remote and on-site visits in Israel with frequent travel.
Apraksts
- Coordinate clinical monitoring and site management for clinical trials.
- Visit sites remotely and in person to check protocol and regulatory compliance.
- Manage required records and follow sponsor and monitoring procedures.
- Keep trials aligned with approved protocols, ICH-GCP guidance, regulations and standard operating procedures.
- Monitor investigator sites using a risk-based approach.
- Analyze root causes and implement corrective and preventive actions.
- Check data accuracy through source data review, source data verification and case report form review.
- Review investigational product inventory and related records.
- Record findings in reports and letters, and track deficiencies through resolution.
- Stay in contact with investigator sites between monitoring visits.
- Carry out monitoring work according to approved monitoring plans.
- Support investigator payments and participate in investigator meetings.
- Identify potential investigators and help initiate clinical trial sites.
- Close out trials and retrieve study materials.
- Confirm essential documents are complete and review site files in person.
- Track study status and share progress updates.
- Keep study systems, including clinical trial management systems, accurate and current.
- Coordinate communication among investigator sites, the client and internal project teams.
- Address company, client and regulatory requests, audits and inspections.
- Submit expense reports and timesheets.
- Support project publications and tools, and contribute to process improvements.
Prasības
- Bachelor’s degree in a life sciences field, registered nursing certification, or equivalent relevant academic or vocational qualification.
- One to two years of experience as a clinical research associate or monitor.
- Valid driver’s license where applicable.
- Equivalent qualifications may be considered through a combination of relevant education, training or directly related experience.
- Basic knowledge of a medical or therapeutic area and familiarity with medical terminology.
- Working knowledge of ICH-GCP, applicable regulations and procedural documents.
- Clear oral and written communication, including communication with medical personnel.
- Strong interpersonal skills.
- Customer focus, attentive listening and careful attention to detail.
- Organizational and time management skills.
- Flexibility and adaptability.
- Critical thinking, root cause analysis and problem-solving skills.
- Ability to manage risk-based monitoring concepts and processes.
- Ability to work independently and collaboratively.
- Sound knowledge of Microsoft Office and ability to learn relevant software.
- Good English language and grammar skills.
- Willingness and ability to travel frequently, generally 60–80%, including possible overnight stays.
- Ability to work in office, laboratory, clinical and/or home office settings.
- Ability to use required personal protective equipment and work around biological fluids or infectious organisms.
Priekšrocības
- Fully remote work arrangement.
- Standard Monday to Friday schedule.