Thermo Fisher Scientific ғылыми зерттеулер мен денсаулық сақтау саласын қолдайтын технологияларды, зертханалық өнімдерді және фармацевтикалық қызметтерді әзірлеп, ұсынады. Компанияның қызметі өмір туралы ғылымдар саласындағы зерттеулерді, аналитикалық мәселелерді шешуді, зертхана өнімділігін арттыруды, диагностика жүргізуді, сондай-ақ емдеу әдістерін әзірлеу мен өндіруді қамтиды. Компания Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon және PPD сияқты брендтер портфелі мен жаһандық командасы арқылы клиенттерге қызмет көрсетеді. Оның мансаптық бағыттары осы ұсыныстардың негізіндегі ғылыми, денсаулық сақтау, өндірістік, логистикалық және сервистік операцияларды қамтиды.
Principal Clinical Research Associate (Remote, United States)
Lead clinical trial monitoring for Thermo Fisher Scientific’s global research programs, supporting site compliance, data quality, audit readiness, and patient safety.
Сипаттама
- Oversee clinical monitoring and site management across assigned studies.
- Conduct remote and on-site visits using risk-based monitoring methods.
- Review source data, verify source records, and assess case report forms as needed.
- Check investigational product accountability against inventory and records.
- Spot site process gaps and put corrective and preventive actions in place.
- Track site deficiencies and issues through documentation, escalation, and resolution.
- Keep in touch with investigational sites between monitoring visits.
- Confirm trials follow approved protocols, ICH-GCP, regulations, SOPs, and procedures.
- Keep essential study records complete, accurate, and compliant with regulatory requirements.
- Review site files and help prepare for audits and inspections.
- Start up clinical trial sites and assist with their close-out.
- Attend investigator meetings and help identify and assess prospective study sites.
- Address audit and inspection requests from the company, sponsors, and regulators.
- Report study status and progress to the Clinical Team Manager.
- Keep study systems, including CTMS, accurate and up to date.
- Check the quality of reports generated by CTMS.
- Coordinate communication among sites, sponsors, and project teams.
- Help develop project tools and communications, contribute to publications and process improvements, and share best practices.
- Assist with other study work, such as reviewing trip reports, preparing newsletters, or leading CRA team calls.
- Take part in investigator payment activities.
- Submit accurate expense reports and timesheets on time.
Талаптар
- Bachelor’s degree in a life sciences field, registered nursing qualification, or equivalent relevant academic or vocational credential.
- At least two years of experience as a Clinical Research Monitor or CRA, or comparable relevant experience.
- Valid driver’s license where applicable.
- Equivalent combinations of education, training, and directly related experience may be considered.
- Strong clinical monitoring and site management capabilities.
- Sound understanding and practical use of ICH-GCP, applicable regulations, and clinical research procedures.
- Knowledge of medical terminology and relevant therapeutic areas.
- Experience applying risk-based monitoring (RBM) principles and processes.
- Strong critical thinking, root-cause analysis, and problem-solving skills.
- Careful attention to detail, with strong organization and time management.
- Clear written and verbal communication, including confidence communicating with medical professionals and investigational site staff.
- Strong interpersonal skills and a collaborative, customer-focused approach.
- Able to adapt to changing priorities and work independently or with a global team.
- Proficient in Microsoft Office and able to learn clinical trial systems and software quickly.
- Good written and spoken English.
- Strong presentation skills.
- Able to travel frequently, typically 60–80%.
- Able to drive regularly to clinical trial sites.
- Able to take extended and overnight trips when needed.
- Able to meet applicable sponsor, client, and investigational site requirements.
Артықшылықтар
- Work on varied, innovative global clinical research programs.
- Gain exposure to a wide range of sponsors, therapeutic areas, and trial settings.
- Join a collaborative, inclusive culture that values your expertise and ideas.
- Access ongoing learning, professional development, and career growth opportunities.
- Competitive compensation and benefits.
- Personal protective equipment is provided or required when exposure to biological materials calls for it.