12 часов назад
Senior Clinical Research Associate I
82 700 - 137 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate I (Clinical Trial Monitoring): Managing and monitoring investigator sites throughout clinical trials with an accent on patient safety, GCP compliance, site quality, and timely study delivery. Focus on resolving protocol and data issues, supporting recruitment and database release, and conducting site initiation, routine monitoring, and close-out activities with 60–80% travel.
Location: New York City, United States. Significant travel of 60–80% within the area is required, with possible international and weekend travel. Permanent U.S. work authorization and authorization to be employed in the U.S. by any employer are required.
Annual base salary: $82,700–$137,900, plus eligibility for a 10% bonus target.
Company
develops medicines and conducts clinical research to advance patient care.
What you will do
- Manage and monitor assigned investigator sites from site initiation through database lock and study close-out.
- Ensure clinical trials follow monitoring plans, applicable laws, ICH/GCP requirements, and standards.
- Serve as the primary contact for investigator sites and coordinate information flow with study teams and vendors.
- Support site training, recruitment, enrollment, protocol issue resolution, adverse-event follow-up, and data-query resolution.
- Oversee investigational product handling, storage, accountability, and destruction at investigator sites.
- Support audits, CAPA development, database release, co-monitoring, and mentoring of Clinical Research Associates.
Requirements
- Bachelor’s or professional degree in life sciences, nursing, pharmacy, medicine, or an equivalent field.
- At least 3 years of relevant clinical research site-monitoring experience; 2 years in oncology is preferred.
- Extensive knowledge of clinical trial methodology, ICH/GCP, FDA requirements, and local regulations.
- Experience with global clinical trials, site monitoring, regulatory interactions, protocol feasibility, data management, and risk mitigation.
- Fluent English and fluency in the native language(s) of the country of work are required.
- Valid driver’s license and passport required; ability to travel extensively and work in a matrix environment.
Nice to have
- Therapeutic experience in oncology, vaccines, internal medicine, or infectious diseases.
- Experience as an unblinded monitor or subject-matter expert for CRA processes.
Culture & Benefits
- Full-time employment with eligibility for ’s Global Performance Plan.
- 401(k) plan with matching contributions and an additional retirement savings contribution.
- Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
- Medical, prescription drug, dental, and vision coverage.
- Relocation assistance may be available based on business needs and eligibility.
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