9 часов назад
Clinical Research Associate
68 600 - 114 300$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate (Clinical Trials): Managing and monitoring investigator sites from study initiation through database lock and close-out, with an accent on patient safety, GCP compliance, site quality, and clinical trial delivery. Focus on resolving protocol and data issues, supporting recruitment, overseeing investigational products, and coordinating corrective actions across investigator sites and study teams.
Location: New York City, United States. Significant travel of 60–80% within the assigned area is required, with possible international and weekend travel. A valid driver's license and passport are required.
Annual base salary: $68,600–$114,300, plus eligibility for a 7.5% bonus target.
Company
conducts clinical development programs and clinical trials in collaboration with investigator sites and healthcare professionals.
What you will do
- Manage, monitor, and close assigned investigator sites from site initiation through database lock.
- Ensure clinical trials follow the monitoring plan, applicable laws, ICH/GCP requirements, and standards.
- Serve as the primary contact for investigator sites, supporting enrollment, protocol training, issue resolution, and site engagement.
- Conduct onsite and remote monitoring, assess electronic diary data, and oversee site-level adverse and serious adverse event reporting.
- Maintain trial documentation and tracking, including Trial Master File records, site reports, protocol deviations, recruitment metrics, and clinical supplies.
- Oversee investigational product handling and support database release, audit activities, and CAPA development when required.
Requirements
- Bachelor’s or professional degree in life sciences, nursing, pharmacy, medicine, or an equivalent field.
- At least one year of relevant clinical research site monitoring and management experience.
- Knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and local regulations.
- Fluent English and fluency in the native language or languages of the country of employment.
- Ability to evaluate and present complex clinical issues and data, manage risk, and work effectively in a matrix team.
- Permanent U.S. work authorization and authorization to work in the U.S. for any employer are required; visa sponsorship is not available.
Nice to have
- Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases.
- Global clinical trial experience.
Culture & Benefits
- Full-time employment with comprehensive benefits.
- 401(k) plan with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, and caregiver, parental, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Work includes regular collaboration with investigator sites, healthcare professionals, vendors, and cross-functional study teams.
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