6 дней назад
Senior CRA
130 000 - 145 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior CRA (Clinical Research): Leading site monitoring for non-invasive neuromonitoring clinical studies, including on-site and remote visits, IRB coordination, and trial documentation with an accent on GCP compliance, site relationships, and study quality. Focus on monitoring investigator sites, resolving data queries, managing protocol deviations and CAPA activities, and maintaining regulatory readiness across a clinical programme.
Location: Remote within the US; applicants must reside in Colorado, Florida, Missouri, Texas, Washington State, or Wisconsin. Expected to work East Coast hours and travel approximately 50% depending on study needs.
Salary: $130,000–$145,000 annually, plus equity.
Company
is developing non-invasive neuromonitoring technology for clinical brain monitoring and the diagnosis and treatment of brain disorders.
What you will do
- Conduct qualification, initiation, interim, and close-out monitoring visits in accordance with GCP, ICH, study protocols, and company SOPs.
- Perform source data review and verification, resolve data queries, and assess site performance, protocol adherence, and enrollment progress.
- Identify and escalate site issues, deviations, and risks; support CAPA development and inspection and audit readiness.
- Build relationships with investigator sites and provide training, guidance, and ongoing study support.
- Prepare and track IRB maintenance submissions, including continuing reviews, amendments, and safety updates.
- Maintain Trial Master File quality, support regulatory submissions and site activation, and manage investigational product documentation and accountability.
Requirements
- Substantial clinical research experience, preferably with medical devices.
- Extensive sponsor-side CRA experience with on-site and remote monitoring.
- Strong knowledge of GCP, ICH, FDA, and applicable global clinical research regulations.
- Strong organizational and documentation skills, with the ability to manage multiple site relationships and responsibilities.
- Proficiency with EDC, eTMF, CTMS, and standard office software.
- US residence in one of the permitted states and availability for East Coast hours are required.
Nice to have
- Experience with early feasibility studies, NSR studies, or IDE-regulated frameworks.
- Familiarity with neurology, neurocritical care, traumatic brain injury, or ICU-based clinical settings.
- Experience coordinating IRB submissions and managing sponsor-level regulatory documentation.
Culture & Benefits
- AI is integrated into daily work, collaboration, and innovation.
- Company equity plan.
- Annual unlimited PTO.
- Health, dental, and vision insurance with 50% employer contributions.
- 401(k) plan with an employer match of up to 3%.
- Mental health resources.
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