Clinical Research Associate I: Launch Your Phase I–IV Trials

Mount Sinai Health System; New York (NY); On-site; USD 59,000 - 82,000; Full time

Job summary

The Mount Sinai Health System in New York, NY seeks a Clinical Research Associate I to monitor all aspects of the clinical trial life cycle, from site management through study closure, across Phases I–IV and post-marketing studies.

Responsibilities include preparing essential study documents, monitoring milestones and budgets, maintaining the CTMF, coordinating meetings, and supporting investigator sites with ISF materials.

Qualifications

• Bachelor's Degree in life sciences or BSN required.
• 1-2 years of experience in relevant Clinical Research is required or desirable.

Responsibilities

• Monitors all aspects of clinical research trial life-cycle, including site management, maintenance and closure of studies (Phase I–IV and post-marketing).
• Prepares and edits critical study documents (protocols, synopses, flowcharts, informed consent templates, monitoring guidelines, ISF, vendor/ CRO documents, agreements).
• Monitors resources and reports to deliver milestones on time and within budget.
• Maintains clinical trial master file (CTMF) documentation in compliance with SOPs and guidelines.
• Assists in preparing materials for clinical study conduct and site files (ISF) for investigators.
• Coordinates investigator site recruitment and maintains current contact information for investigators.
• Collects pre-study documentation and essential regulatory documents from sites; updates documents during study.
• Estimates, orders and coordinates shipments of study supplies to investigator sites.
• Supports CTM with tracking grant payments and study budgets.
• Tracks adverse events and protocol deviations; communicates findings to sites and CTM.
• Reviews adverse events for safety issues and patterns; reports findings to CTM.

Education

Bachelor's Degree in life sciences or BSN

Job description

The Mount Sinai Health System in New York, NY seeks a Clinical Research Associate I to monitor all aspects of the clinical trial life cycle, from site management through study closure, across Phases I–IV and post-marketing studies.

Responsibilities include preparing essential study documents, monitoring milestones and budgets, maintaining the CTMF, coordinating meetings, and supporting investigator sites with ISF materials.