Clinical Research Associate I: Trial Operations & Compliance

Mount Sinai Health System; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

Mount Sinai Health System is seeking a Clinical Research Associate I to monitor all aspects of clinical trial lifecycles across Phase I through Phase IV and post‑marketing studies. You will manage site activities, maintain CTMF, and ensure regulatory compliance while coordinating with CTMs and investigator sites.

The role involves preparing essential study documents, scheduling meetings, collecting regulatory materials, and supporting budget tracking and grant payments.

Qualifications

• Bachelor's degree in life sciences or BSN.
• 1-2 years of experience in clinical research.
• Experience in Phase I–IV clinical studies is highly desirable.

Responsibilities

• Monitor all aspects of the clinical trial lifecycle, from site management to maintenance and closure of studies.
• Prepare and edit critical study documents (protocols, informed consent templates, monitoring guidelines, etc.).
• Monitor resources and timelines to meet milestones on time and within budget.
• Maintain and file the clinical trial master file (CTMF) in compliance with SOPs and guidelines.
• Coordinate and host study team meetings, including agenda, minutes, and distribution.

Skills

Clinical trial coordination

Documentation skills

Regulatory compliance

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 trial lifecycles across Phase I through Phase IV and post‑marketing studies. You will manage site activities, maintain CTMF, and ensure regulatory compliance while coordinating with CTMs and investigator sites.

The role involves preparing essential study documents, scheduling meetings, collecting regulatory materials, and supporting budget tracking and grant payments.