Clinical Research Associate I-Cardiovascular Surgery

About the role

The Clinical Research Associate I monitors all aspects of clinical research trial(s) and oversees the clinical study life‑cycle, 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; laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.).
• Monitors resources/reports to deliver milestones on time and within budget.
• Collects, reviews, and files all clinical study documentation for assigned trial(s) and investigative sites, maintaining the clinical trial master file (CTMF) in compliance with applicable guidelines and SOPs.
• Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing minutes, and copying minutes to the 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 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 the investigator site file for participation approval.
• Collects pre‑study documentation and essential regulatory documents from assigned investigator sites, and updates 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 the study budget.
• Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites, and communicates with sites on routine matters.
• Reviews all adverse events reported in the clinical study for identification and evaluation of safety issues and any identifiable 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 all documents collected for the study and initiates the 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.

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.

Employer Description

Strength through Unity and Inclusion – The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual. Our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow, driving collaboration, fairness, and continuous learning.

About the Mount Sinai Health System

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees across eight hospitals, over 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. The system advances health for all people by tackling complex health‑care challenges, discovering new scientific knowledge, developing safer treatments, educating future medical leaders, and supporting local communities. Through integrated hospitals, labs, and schools, Mount Sinai offers comprehensive health‑care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence while keeping patients’ medical and emotional needs at the center of care. The system includes over 9,000 physicians, 13 joint‑venture outpatient surgery centers, and more than 30 affiliated community health centers. It is consistently ranked by U.S. News & World Report, with top positions in geriatrics, cardiology, and numerous other specialties.

Compensation

The salary range for this role is $58,661 – $81,675 annually. Actual salaries depend on experience, education, and operational need.