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

About the Role

The Clinical Research Associate I monitors all aspects of clinical research trials, including site management, ongoing maintenance, and closure of pre-clinical, Phase I through Phase IV, and post-marketing studies.

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 for laboratory, vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets).
• Monitors resources and reports to deliver milestones on time and within budget.
• Collects, reviews, and files all clinical study documentation for assigned trials and investigative sites, maintaining the clinical trial master file (CTMF) in compliance with applicable guidelines and SOPs.
• Participates in the preparation and hosting of clinical study team meetings, providing agendas, recording/distributing minutes, and sharing them with the CTM.
• Works with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites, provided as an investigator site file (ISF).
• Prepares, collects, and archives all study-related correspondence to investigator sites, including newsletters, Dear Dr. letters, FDA/HA correspondence, and contractual agreements.
• Responsible for investigator recruitment, maintaining current contact information for assigned sites, and preparing investigator site files for participation approval.
• Collects pre-study documentation and essential regulatory documents from assigned sites, as well as updated documents prior to study initiation and on an ongoing basis.
• Estimates, orders, and coordinates shipments of clinical study supplies to assigned sites.
• Assists the CTM with tracking and requesting grant payments and maintains the study budget.
• Tracks and reports adverse events, protocol deviations, and other unusual activity at assigned sites, communicating routinely with sites.
• Reviews adverse events reported in clinical studies to identify and evaluate safety issues and patterns.
• 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 study documents and initiates the data clarification/validation process.
• Assists in preparing clinical reports for submission to regulatory authorities.
• Performs other duties as required.

Qualifications

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

About the Employer

The Mount Sinai Health System is committed to fostering an inclusive environment where everyone contributes to excellence. We share a dedication to delivering outstanding patient care and transforming healthcare through innovation, education, and research.

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with over 48,000 employees across eight hospitals, 400+ outpatient practices, 300+ labs, a school of nursing, and a leading school of medicine. We advance health for all by tackling complex challenges, discovering new scientific knowledge, and delivering high-quality care.

Ranked highly in specialties such as Geriatrics, Cardiology/Heart Surgery, Diabetes/Endocrinology, and more, Mount Sinai is recognized for excellence in patient care, research, and education. The Icahn School of Medicine at Mount Sinai is a top recipient of NIH funding, and our hospitals are consistently ranked among the best globally.

Pay

The salary range for this role is $58,661 - $81,675 annually. Actual salaries depend on experience, education, and operational need and do not include bonuses, incentive pay, or other forms of compensation.