The Clinical Research Associate I monitors all aspects of clinical research trial(s) Clinical study life-cycle responsibilities 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 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.

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.

Strength through Unity and Inclusion

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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 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.

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