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Alira Health — өмір туралы ғылымдар саласындағы ұйымдарға қызмет көрсететін жаһандық денсаулық сақтау жөніндегі консалтинг және технология компаниясы. Оның қызметі зерттеу және клиникалық әзірлеу, нормативтік талаптарға сәйкестік, басқару консалтингі, пациенттерді тарту және нарыққа қолжетімділікті, сондай-ақ өмір туралы ғылымдар саласындағы зерттеулерді қолдауға арналған технологиялық шешімдерді қамтиды. Компания эмпатияға, ғылыми жетістіктерге, пациенттердің нәтижелеріне, экологиялық тұрақтылыққа, қоғамдастыққа қатысуға және ESG бастамаларына баса мән береді.
Clinical Research Associate – Massachusetts Remote
Clinical Research Associate supporting Alira Health clinical trials remotely from Massachusetts. The role focuses on site oversight, data integrity, regulatory compliance, and study quality.
Сипаттама
- Monitor clinical trial sites and activities.
- Provide oversight, leadership, and guidance throughout clinical trial management and execution.
- Maintain protocol compliance and study quality while meeting SOP, timeline, and budget requirements.
- Review monitoring visit reports and complete co-monitoring and evaluation visits.
- Ensure investigator site visits occur on schedule.
- Coordinate with cross-functional teams to address clinical trial monitoring issues.
- Support Monitoring Plans, training materials, ethics documentation, and site contract negotiations.
- Conduct qualification, initiation, interim, and close-out visits both remotely and onsite.
- Produce accurate monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment.
- Verify source documentation and protect CRF data integrity.
- Complete quality-control reviews and document verification for eTMF and TMF records.
- Track investigational product accountability and review regulatory binders.
- Stay in contact with study sites about protocol and GCP compliance, accrual, and sponsor requests.
- Support adverse event reporting and reconcile SAE reports against source records and CRFs.
- Resolve discrepant data queries with in-house CRAs, CTC, and data management teams.
- Identify site challenges and develop effective resolution strategies.
- Prepare study sites for audits.
- Mentor CRAs and support CRA onboarding and training.
- Contribute to CTMS development and maintenance.
- Balance competing priorities and complete other assigned responsibilities.
Талаптар
- At least two years of monitoring experience.
- Ability to build and maintain positive relationships with sponsors, sites, and project team members.
- Ability to manage monitoring activities independently.
- Quality-focused approach with demonstrated care, thoroughness, and attention to detail.
- Strong organization and multitasking skills in a fast-paced work environment.
- Ability to prioritize work, manage time, and solve problems effectively.
- Strong analytical, negotiation, meeting-management, cross-functional collaboration, and leadership skills.
- Willingness and ability to travel.
- Ability to manage stress effectively.
- Professional, trustworthy, and disciplined conduct.
- Ability to address unstructured or ambiguous challenges through problem-solving.
- Strong written and verbal command of the local language in the country where monitoring activities are performed.
- Excellent communication and interpersonal skills with a customer-service mindset.
- Proficiency with computers, including clinical trial management systems, clinical trial databases, and electronic data capture tools.
- Working knowledge of clinical research, ICH GCP, and applicable local regulations.
- Knowledge of regulatory and ethical requirements.
- English proficiency.
- Bachelor of Science degree in Biology or Life Sciences.
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