Evolution Research Group innovatsion klinik tadqiqotlar orqali yangi davolash usullarini ishlab chiqishni qo‘llab-quvvatlaydigan sog‘liqni saqlash va biotexnologiya sohasidagi klinik tadqiqot tashkilotidir. Uning faoliyati psixiatriya, nevrologiya, og‘riqni boshqarish, qaramlik va surunkali kasalliklar yo‘nalishlarini qamrab oladi. Tashkilot dastlabki bosqichdagi tadqiqotlar va ishtirokchilarni samarali jalb etishga e’tibor qaratadi. Tadqiqotlardan foydalanish imkoniyatini kengaytirish hamda klinik tadqiqotlar xizmat ko‘rsatilayotgan bemorlarning ehtiyojlarini aks ettirishini ta’minlash uchun tashkilot tibbiy xizmat ko‘rsatuvchilar va bemorlar manfaatlarini himoya qiluvchi guruhlar bilan hamkorlik qiladi.
Senior Clinical Research Associate (CRA) – Maryland Remote Contract
Contract Senior Clinical Research Associate overseeing clinical trial sites for Lotus Clinical Research. The role covers GCP compliance, essential documentation, investigational product accountability, and study close-out.
Tavsif
- Independently oversee and monitor site activities across assigned clinical studies
- Conduct site qualification, initiation, interim monitoring, and close-out visits
- Maintain compliance with study protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP requirements
- Evaluate clinical sites and assess investigator and site capabilities
- Lead study initiation tasks, review protocols and regulatory matters, and train site personnel
- Keep Investigator Site Files audit-ready and upload required documents to the Trial Master File
- Coordinate with investigational sites on visit scheduling, query resolution, action items, and site management
- Track clinical trial material accountability, stability, and storage conditions, and complete investigational product inventories
- Manage site correspondence and support timely clinical data transmission
- Complete close-out visits, investigational product reconciliation and disposition, study file reconciliation, database-lock query resolution, and remaining action items
- Finish internal and study-specific training within required deadlines
- Handle pre- and post-visit follow-up, including confirmation letters, follow-up correspondence, and monitoring reports
- Partner with the CRA Line Manager on CRA and junior staff mentoring, training, and assessment when applicable
Talablar
- Bachelor’s degree or equivalent experience in life sciences or healthcare
- At least five years of field experience as a Clinical Research Associate
- Demonstrated mastery of CRA II responsibilities
- Valid driver’s license
- Legal authorization to work in the United States as an independent contractor through an LLC, INC., or agency
- Ability and willingness to travel up to 100% domestically by land and air
- Expertise in drug development, ICH guidelines, GCP, and clinical trial operations
- Proficiency with electronic case report form platforms and related processes
- Strong interpersonal, organizational, and multitasking abilities
- Exceptional attention to detail and professional judgment
- Ability to uphold ICH GCP requirements and select appropriate responses to complex issues
- Capacity to manage multiple deadlines while working independently
- Proficiency with computers, email, document, spreadsheet, and presentation software
- Ability to submit invoices and expense reports on time in accordance with Finance Department requirements
- Ability to meet physical requirements, including occasional lifting or carrying of up to 10 pounds
- Willingness to follow safety, environmental, infection-control, and protective-equipment requirements while traveling to or visiting clinical research sites
Imtiyozlar
- The contractor is responsible for obtaining and maintaining personal insurance
- Option to work from a home office
- Opportunity to mentor, train, and assess CRAs and junior staff