обновлено 5 дней назад
In-House Clinical Research Associate I, Sponsor-Dedicated (Contract)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
In-House Clinical Research Associate I, Sponsor-Dedicated (Contract) (Clinical Trials): Supporting clinical operations and monitoring trials for biotech, medtech, and specialty pharma programs with an accent on remote monitoring, safety reporting, compliance, and study-site coordination. Focus on identifying and escalating non-compliance, reviewing study data, supporting audits and inspections, and resolving trial issues.
Location: United States of America; preferred location: East Coast or Central
Company
provides functional clinical research services for biotech, medtech, and specialty pharmaceutical companies developing medicines, devices, and diagnostics.
What you will do
- Support clinical operations teams, study sites, and cross-functional partners throughout all trial phases.
- Carry out remote monitoring of clinical trials and serve as a secondary site contact for CRAs.
- Report and follow up on serious adverse events and other reportable events according to protocols, regulations, and applicable requirements.
- Identify, document, communicate, and escalate non-compliance issues using monitoring visits, study metrics, and study data reviews.
- Support audit and inspection readiness, study start-up, data listing reviews, monitoring visits, and issue resolution.
Requirements
- Bachelor's degree or international equivalent, preferably in a clinical, biological, scientific, or health-related field, or an equivalent combination of education, training, and experience.
- 3–5 years of practical clinical trial experience or proven experience performing the primary responsibilities of the role.
- Strong English verbal and written communication skills.
- Ability to participate in study-specific meetings, teleconferences, and training.
- Ability to deliver quality and timely work, take ownership of tasks, and support positive customer interactions.
- Experience in neurology or psychiatry, including work with Schedule I controlled substances, is preferred.
Culture & Benefits
- Full-time 1099 contract position for 12 months, with potential extension and renewal after one year.
- Flexible working practices and support for work-life balance.
- Opportunities to develop skills and grow within clinical research services.
- Employee ideas and input are encouraged.
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