Clinical Research Coordinator I- The Mindich Child Health and Development Institute

The Clinical Research Coordinator assists in the daily activities of clinical research studies, obtains informed consent; collects, maintains and organizes study information. Assists in preparing grant applications and documents (for e.g., Institutional Review Board, Grants and Contracts Office).

• Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects.
• Ensures accurate and complete compilation of subject data through chart reviews.
• Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.  
• Obtains informed consent under minimal supervision of the investigator(s) and educates participants regarding study requirements.
• Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
• Maintains source documents and subject files in accordance with hospital procedures.  Ensures accurate and complete compilation of subject data through chart reviews. Inputs all information into database. 
• Obtain, process, store, and ships clinical specimens as required by the protocol.   
• Prepares for monitoring visits. 
• Support the regulatory affairs team to ensure compliance with FDA regulations, ICH-GCP guidelines, and other relevant local and international regulations for clinical trials and studies
• Maintains the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements
• Work closely with cross-functional teams to ensure that regulatory documentation is accurate, complete, and submitted in a timely manner
• Ensure the integrity of clinical trials, maintaining regulatory compliance and contributing to the overall success of research initiatives
• Additional duties include operational assistance with other essential systems, as well as a variety of special projects; once an understanding of the general duties listed below has been acquired, this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the PCTO

• Bachelors or Masters degree in Science or closely related field.
• 1-2 years of research experience

 

 

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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 spe