Clinical Research Associate I – Trials & Site Lead

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

Job summary

Mount Sinai Health System is seeking a Clinical Research Associate I to monitor all aspects of clinical research trials across the study life cycle. The role includes site management, documentation, and ensuring compliance with guidelines and SOPs.

The candidate will assist with investigator recruitment, regulatory submissions, budget tracking, and coordination of study materials and shipments. A life sciences BS or BSN and 1–2 years in clinical research are preferred.

Qualifications

• Bachelor's Degree in life sciences or BSN.
• 1-2 years experience in relevant Clinical Research. Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable.

Responsibilities

• Prepares and completes critical study documents and performs final editing/proofing prior to publishing.
• Monitors resources/reports to deliver milestones on time and budget.
• Collects, reviews and files all clinical study documentation for assigned trial(s) and maintains the clinical trial master file (CTMF).
• Participates in preparation and hosting of clinical study team meetings, providing agenda and distributing minutes.
• Assists in compiling materials for clinical study conduct and site files for investigators.
• Prepares and archives study-related correspondence to investigator sites.
• Responsible for investigator recruitment and maintaining contact information.
• Collects pre-study documentation and essential regulatory documents.
• Coordinates shipments of clinical study supplies.
• Assists CTM with tracking grant payments and budgets.
• Tracks and reports adverse events and protocol deviations.
• Reviews adverse events for safety patterns and reports findings.
• Prepares documentation for Clinical Event Committee meetings, if applicable.
• Identifies data errors and initiates data clarification/validation.

Education

Bachelor's degree in life sciences or BSN

Job description

Mount Sinai Health System is seeking a Clinical Research Associate I to monitor all aspects of clinical research trials across the study life cycle. The role includes site management, documentation, and ensuring compliance with guidelines and SOPs.

The candidate will assist with investigator recruitment, regulatory submissions, budget tracking, and coordination of study materials and shipments. A life sciences BS or BSN and 1–2 years in clinical research are preferred.