Clinical Research Associate I: Study Ops & Compliance

Icahn School of Medicine at Mount Sinai; New York (NY); On-site; USD 59,000 - 82,000; Full time

Job summary

The Icahn School of Medicine at Mount Sinai is seeking a Clinical Research Associate I to monitor all aspects of clinical trial lifecycle across sites. You will prepare and finalize essential study documents, ensure regulatory compliance, and coordinate with investigators to maintain study files and budgets.

Responsibilities include site coordination, preparing materials for study conduct, tracking adverse events, and assisting during CTM meetings.

Qualifications

• Bachelor's degree in life sciences or BSN required.
• 1–2 years of experience in clinical research; Phase I–IV experience desirable.

Responsibilities

• Prepares and edits critical study documents for publishing (protocol, synopsis, informed consent templates, etc.).
• Monitors resources and reports to meet milestones on time and budget.
• Maintains CTMF/isf documents and ensures compliance with SOPs and guidelines.
• Assists CTM with meetings, agendas, and minutes distribution.
• Tracks adverse events, protocol deviations, and safety issues; communicates with sites.
• Coordinates shipments of clinical study supplies and supports budget tracking.

Skills

Clinical research

Site management

Study coordination

Education

Bachelor's Degree in life sciences

Tools

Regulatory documents management

Job description

The Icahn School of Medicine at Mount Sinai is seeking a Clinical Research Associate I to monitor all aspects of clinical trial lifecycle across sites. You will prepare and finalize essential study documents, ensure regulatory compliance, and coordinate with investigators to maintain study files and budgets.

Responsibilities include site coordination, preparing materials for study conduct, tracking adverse events, and assisting during CTM meetings.