Alira Health hayot fanlari sohasidagi tashkilotlarga xizmat ko‘rsatuvchi global sog‘liqni saqlash konsalting va texnologiyalar kompaniyasidir. Uning faoliyati tadqiqotlar va klinik ishlab chiqish, me’yoriy talablarga muvofiqlik, boshqaruv konsaltingi, bemorlarni jalb qilish va bozorga kirishni, shuningdek hayot fanlari tadqiqotlarini qo‘llab-quvvatlash uchun ishlab chiqilgan texnologik yechimlarni qamrab oladi. Kompaniya empatiya, ilmiy mukammallik, bemorlar natijalari, ekologik barqarorlik, hamjamiyatdagi ishtirok va ESG tashabbuslariga katta e’tibor beradi.
Clinical Research Associate – Massachusetts Remote
Monitor clinical trials for Alira Health, supporting protocol compliance, site quality, regulatory requirements, and reliable clinical data.
Tavsif
- Monitor clinical trial sites and guide trial management and execution.
- Promote protocol compliance and trial quality.
- Review monitoring reports and carry out co-monitoring and evaluation visits.
- Keep investigator site visits on schedule.
- Coordinate across departments to resolve trial monitoring issues.
- Help develop study monitoring plans and training materials.
- Gather ethics documents and support site contract negotiations.
- Send monthly billing details to Finance.
- Oversee study budgets and serve as sponsor contact for standalone projects.
- Conduct remote and onsite qualification, initiation, interim, and close-out visits.
- Document site issues, resolutions, protocol deviations, study progress, and enrollment in monitoring reports.
- Review and verify source documents and CRF data.
- Check and verify eTMF/TMF documents for quality.
- Track investigational product accountability.
- Review site regulatory binders.
- Maintain site communication on protocol and GCP compliance and patient enrollment.
- Ensure compliance with ICH GCP, FDA regulations, and company and sponsor SOPs.
- Attend internal, client and sponsor, scientific, and other meetings.
- Support adverse event reporting and reconcile SAE reports against source documents and CRFs.
- Resolve data discrepancies with in-house CRAs, CTC, and data management.
- Identify site challenges and develop solutions.
- Prepare study sites for audits.
- Work collaboratively with other CRAs.
- Support CRA training and onboarding.
- Mentor CRAs.
- Contribute to CTMS development and maintenance.
- Balance competing priorities and meet commitments.
- Carry out other assigned duties.
- requirementsExtensions, none
Talablar
- Build and maintain positive relationships with sponsors, sites, and project team members.
- Manage monitoring activities independently.
- Maintain a quality-focused, careful, thorough, and detail-oriented approach.
- Stay organized and manage multiple tasks in a fast-paced setting.
- Set priorities, manage time, and solve problems effectively.
- Bring strong analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.
- Be able to travel.
- Manage stress effectively.
- Demonstrate professionalism, trustworthiness, and discipline.
- Solve unclear or ambiguous challenges.
- Have strong written and spoken command of the local language in the country where monitoring is performed.
- Communicate and work with people effectively, with a customer service mindset.
- Use computers proficiently, including clinical trial management systems, trial databases, and electronic data capture tools.
- Know clinical research, ICH GCP, and local regulations.
- Understand regulatory and ethical requirements.
- Hold a Bachelor of Science degree in Biology or Life Sciences.
- Be proficient in English.
Imtiyozlar
- Remote work arrangement.
- Regular employment contract.