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About the Role

The Clinical Research Associate I monitors all aspects of clinical research trial(s) 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.
Monitors resources/reports to deliver milestones on time and budget.
Collects, reviews, and files all clinical study documentation for assigned trial(s) and investigative sites, and maintains the clinical trial master file (CTMF).
Participates, with the CTM, in the preparation and hosting of clinical study team meetings.
Works with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites.
Prepares, collects, and archives all study-related correspondence to the investigator site.
Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site.
Collects pre-study documentation and essential regulatory documents from assigned investigator sites.
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.
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.
Assists in preparing clinical reports of assigned projects for submission to regulatory authorities.
Performs other duties as required.

Requirements

Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable.

Experience Level

1-2 years experience in relevant Clinical Research

Education Level

Bachelors Degree in life sciences or BSN

Salary/Compensations

$58661 - $81675 Annually

About the Company

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.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow.
We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization.
Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences.
We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally.
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education.
Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment.
The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers.
We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology.
New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology.
U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties.
The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges.
Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws.
We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law.
We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported.
Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.