Clinical Research Associate I - Center for Interventional Cardiovascular Research and Clinical Trials

The Mount Sinai Health System is an academic medical system dedicated to patient care, education, and healthcare innovation. The Clinical Research Associate I monitors clinical research trials across their life cycles, managing site activities, study documentation, regulatory materials, safety reporting, supplies, budgets, and trial milestones.

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Responsibilities

• Prepares and completes critical study documents and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.)
• Monitors resources/reports to deliver milestones on time and budget
• Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs
• Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM
• Works with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF)
• Prepares, collects and archives all study related correspondence to the investigator site including, but not limited to, newsletters, Dear Dr. letters, FDA/HA correspondence, contractual agreements and others
• Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval
• Collects pre-study documentation and essential regulatory documents from assigned investigator sites, as well as, collects updated documents prior to study initiation and on an ongoing basis
• Estimates, orders and coordinates shipments of clinical study supplies to assigned investigator sites
• Assists the CTM with tracking and requesting grant payments, and maintains study budget
• Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters
• Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable
• Reports safety findings in a summary format to the CTM
• Prepares documentation for and attends Clinical Event Committee (CEC) meetings, if applicable
• Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents
• Assists in preparing clinical reports of assigned projects for submission to regulatory authorities
• Performs other duties as required

Preferred

• Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable
• The Mount Sinai Hospital is one of the nation's oldest, largest, and most respected hospitals, and a member of the Mount Sinai Health System.
• New York, NY, US
• http://www.mountsinai.org
• H1B Sponsorship
• Data Powered by
• Distribution of Different Job Fields Receiving Sponsorship
• Represents job field similar to this job
• Education and Training
• Engineering and Development
• Customer Service and Support
• Management and Executive
• Accounting and Finance
• Creatives and Design
• Product Management
• Arts and Entertainment
• Public Sector and Government
• Trends of Total Sponsorships
• *2026
• (61)

Qualifications

• Bachelors 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
• 1-2 years experience in relevant Clinical Research.

Required skills

• Clinical Research, Phase I–IV Clinical Studies

Preferred skills

• (110), (44), (45), (61), (66), (71), (84), *2026, 2020, 2021, 2022, 2023, 2024, 2025, Accounting and Finance, Arts and Entertainment, Creatives and Design, Customer Service and Support, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Education and Training, Engineering and Development, H1B Sponsorship, Management and Executive, New York, NY, US, Product Management, Public Sector and Government, Represents job field similar to this job, Trends of Total Sponsorships, http://www.mountsinai.org

Experience

• 1-2 years